CLS SPOTORNO, EXPANSION SHELL, UNCEMENTED, 56
Report
- Report Number
- 0009613350-2018-00787
- Event Type
- Injury
- Date Received
- August 10, 2018
- Date of Event
- July 19, 2018
- Report Date
- January 10, 2019
- Manufacturer
- ZIMMER GMBH
- Product Code
- LZO
- PMA / PMN Number
- PK953688
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. ADDITIONAL AND CORRECTED INFORMATION ARE FILLED IN THE FOLLOWING FIELDS: ADDITIONAL: AGE OR DATE OF BIRTH, IF FOLLOW-UP, WHAT TYPE. CORRECTION: DATE OF EVENT, DATE OF REPORT, EVENT, OTHER RELEVANT HISTORY, DATE REC¿D BY MFR, PMA/510K. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE, AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
INVESTIGATION RESULTS WERE MADE AVAILABLE. D11, CONCOMITANT DEVICES: - CLS INSERT FOR EXPANSION CUP 28 /56, REF#682856, LOT#: UNKNOWN. - SULOX, HEAD, M, 28/0, TAPER 12/14, REF# 172806, LOT#: UNKNOWN. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: LOOSENING AND FRACTURE OF THE CUP. REVIEW OF EVENT DESCRIPTION: ACCORDING TO THE RECEIVED INFORMATION, THE RETRIEVALS AT HAND WERE REVISED AFTER APPROXIMATELY 19 YEARS IN VIVO. THE ANAMNESIS SECTION OF THE RECEIVED DOCUMENTATION STATES THE PATIENT FELL AND HEARD A CRACKING SOUND FOUR MONTHS BEFORE REVISION. HE DID NOT GO TO THE DOCTOR AND SINCE THEN HE HAD PAIN IN THE LEFT HIP AND WALKING WAS POSSIBLE ONLY WITH THE HELP OF CRUTCHES. SHORTLY BEFORE REVISION THE PATIENT FELL OFF HIS BIKE ON HIS LEFT HIP AND WAS ADMITTED TO THE EMERGENCY ROOM. THE IMAGING PERFORMED BEFORE REVISION REVEALED A LOOSE ACETABULAR COMPONENT AND GRANULOMAS IN THE ACETABULUM AS WELL AS IN THE UPPER THIRD OF THE FEMUR AND IN THE TROCHANTER MAJOR. A REVISION OF CUP AND HEAD WAS PERFORMED. REVIEW OF RECEIVED DATA: - BFARM USER REPORT. THE HOSPITAL REPORTED THE CASE TO THE COMPETENT AUTHORITY ON 26 JUL 2018. IN THE EVENT DESCRIPTION SECTION THE FOLLOWING IS STATED: IMPLANTATION IN 1999, OVER TIME WEAR OF THE PE. IN MAIN LOADING DIRECTION ONE OF THE SHELL¿S SEGMENTS BROKE OFF. FATIGUE FRACTURE? OVERALL LOOSENED CUP, THEREFORE REVISION OF THE CUP. - SURGICAL NOTES: REVISION REPORT FROM (B)(6) 2018: DIAGNOSIS: DISLOCATED BROKEN CLS EXPANSION CUP ON THE LEFT HIP WITH LARGE GRANULOMA IN THE ACETABULUM AND TROCHANTER MAJOR DUE TO PARTICLE DISEASE; STATE AFTER CEMENTLESS TOTAL HIP PROSTHESIS (THP) LEFT IN 1999. PROCEDURE: THE LEFT HIP JOINT IS OPENED THROUGH THE OLD INCISION WHICH IS SLIGHTLY EXTENDED TO PROXIMAL. THE CAPSULE IS OPENED AND SEROUS, SLIGHT BLOODY EFFUSION DRAINS. THE CLEARLY SCARRED CAPSULE AROUND THE ENTIRE HIP JOINT IS REMOVED. THE FEMORAL HEAD IS IN THE CUP, THE CUP IS COMPLETELY TURNED OUT OF POSITION. GRANULATION TISSUE IS REMOVED AND THEN THE CUP CAN BE REMOVED. A SEGMENT OF THE CLS EXPANSION CUP IS BROKEN AND NEEDS TO BE REMOVED SEPARATELY. THE TROCHANTER MAJOR IS TREATED VERY CAREFULLY, BECAUSE THERE ARE GRANULOMAS AS WELL. FORTUNATELY, A TROCHANTER FRACTURE DID NOT APPEAR. THE STEM IS FIX. THE FEMORAL HEAD IS REMOVED AND THE STEM¿S STABILITY IS CHECKED AGAIN. THEN THE ACETABULUM IS CAREFULLY PREPARED. THE ACETABULAR BOTTOM IS MISSING ON AN AREA OF ABOUT THE SIZE OF A TWO EURO COIN. THERE IS ONLY SOFT TISSUE. CRANIALLY THERE ARE SOME SMALL HOLES WHICH ARE SCRAPED OUT WITH THE SHARP SPOON. EXTENSIVE JET LAVAGE IS PERFORMED. OVERALL, AS EXPECTED FROM THE PREVIOUS IMAGING THERE IS A RELATIVELY LARGE DEFECT. THE ISCHIUM IS PREPARED WITH THE BURCH-SCHNEIDER CHISEL. THEN, CANCELLOUS BONE CHIPS AND A FOREIGN FEMORAL HEAD CUT INTO SLICES ARE INSERTED INTO THE BOTTOM OF THE ACETABULUM AS AN ABUTMENT AND THE BONE CHIPS ARE PRESSED TO CRANIALLY. THE BURCH-SCHNEIDER CAGE IS TAPPED IN GENTLY AND FIXED WITH A CENTRAL SCREW. THEN THREE MORE SCREWS ARE INSERTED. OVERALL THERE IS A RELATIVELY GOOD FIT. CANCELLOUS BONE IS INTRODUCED THROUGH THE HOLES OF THE BURCH-SCHNEIDER CAGE AND THEN A SIZE 52 CUP IS CEMENTED UNDER PRESSURE. AFTER HARDENING OF THE CEMENT A MERETE CERAMIC HEAD, SIZE 36M WITH A 7.5° VARUS, IS PLACED. WITH THIS THERE IS A GOOD MOBILITY AND OVERALL STABLE CONDITIONS. ANOTHER EXTENSIVE RINSING IS MADE AND THE WOUND IS CLOSED. - REVISION REPORT FROM (B)(6) 2018: DIAGNOSIS: LARGE SUBCUTANEOUS SEROMA AFTER REVISION OF THE CUP OF A HIP ENDOPROSTHESIS IMPLANTED YEARS AGO. PROCEDURE: WOUND REVISION, EXTENSIVE DEBRIDEMENT, MICROBIOLOGY AND HISTOLOGY SAMPLING 5 TIMES EACH, EXTENSIVE RINSING WITH LAVANID AND NACL, WOUND CLOSURE. - HOSPITAL DISCHARGE LETTER, DATED (B)(6) 2018. THE LETTER REPORTS ABOUT THE PATIENT¿S HOSPITAL STAY FROM (B)(6) 2018. DIAGNOSIS: CUP LOOSENING LEFT HIP. SUBCUTANEOUS SEROMA AFTER REVISION OF THE LEFT HIP PROSTHESIS. POSTOPERATIVE ANEMIA. CONCUSSION WITH RETROGRADE AMNESIA. ABSOLUTE ARRHYTHMIA / CARDIAC FIBRILLATION. THERAPY: - ON (B)(6) 2018: BURCH-SCHNEIDER CAGE, ALLOGENIC CANCELLOUS BONE GRAFT AT THE BOTTOM OF THE ACETABULUM, PE CUP 52/36, SAMPLE TAKING FOR HISTOPATHOLOGICAL AND MICROBIOLOGICAL EXAMINATION - ON (B)(6) 2018: WOUND REVISION, EXTENDED DEBRIDEMENT, FIVE SAMPLES TAKEN FOR HISTOPATHOLOGICAL AND MICRO-BACTERIOLOGICAL EXAMINATION EACH, ABUNDANT RINSING WITH LAVANID AND NACL, WOUND CLOSURE - ON (B)(6) 2018: REVISION OF THE LEFT TOTAL HIP PROSTHESIS WITH LAVANID RINSING, CHANGE OF THE ARTICULATING COMPONENTS (CEMENTED DURASUL SIZE 50, BIOBALL SIZE 12/14, BIOLOX DELTA SIZE 36) - ANTIBIOTIC TREATMENT WITH VANCOMYCIN, RIFAMPICIN AND LINEZOLID - ANAMNESIS AND EXAMINATION FINDINGS: THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM AFTER HE FELL OFF HIS BIKE ON HIS LEFT HIP. THE PATIENT DOES NOT REMEMBER THE FALL, HE SAID HE HAD DRUNK A BEER. STATE AFTER TWO LEFT HIP SURGERIES, STATE AFTER THP ON BOTH SIDES. THE PATIENT REPORTED TO HAVE HAD PROBLEMS WITH THE LEFT HIP FOR FOUR MONTHS. HE FELL AND HEARD A CRACKING SOUND BUT DID NOT GO TO THE DOCTOR. SINCE THEN WALKING WAS ONLY POSSIBLE WITH THE HELP OF CRUTCHES. PAIN IN THE LEFT HIP, ACCORDING TO THE PATIENT, FOR APPROXIMATELY 4 MONTHS. SHORTENED LEG, PROBABLY SINCE THE FIRST HIP SURGERY. - PELVIS OVERVIEW AND AP PELVIS FROM (B)(6) 2018. BILATERAL THP. PROSTHESIS DISLOCATION ON THE LEFT HIP WITH LOOSENING OF THE ACETABULAR COMPONENTS. SMOOTH AND SHARP CORTICAL DEMARCATION OF THE IMAGED BONES WITHOUT SUSPICIOUS CONTOUR INTERRUPTION. - CT OF THE LEFT HIP JOINT FROM (B)(6) 2018. EXTENSIVE PE GRANULOMA WITH CLEAR LOOSENING OF THE CUP OF THE LEFT HIP PROSTHESIS. ANOTHER PE GRANULOMA IN THE UPPER THIRD OF THE FEMUR AS WELL AS TROCHANTER MAJOR. - LEFT HIP JOINT IN TWO VIEWS AND PELVIS AP FROM (B)(6) 2018. NORMAL POSTOPERATIVE FINDING AFTER REVISION OF THE LEFT THP WITH A BURCH-SCHNEIDER CAGE. - PELVIS AP AND LEFT HIP FROM (B)(6) 2018. COMPARISON WITH THE PREVIOUS EXAMINATION FROM (B)(6) 2018. REGRESSION OF THE SOFT TISSUE EMPHYSEMA AND SOFT TISSUE SWELLING. OTHERWISE, NO SIGNIFICANT CHANGES. - THERAPY AND PROGRESS: IN THIS SECTION IT IS STATED THAT THE SAMPLES TAKEN DURING THE SURGERY GAVE EVIDENCE OF STAPHYLOCOCCUS PASTEURI, LUGDUNENSIS AND HAEMOLYTICUS AND IN ADDITION STAPHYLOCOCCUS MITIS SENSITIVE TO VANCOMYCIN. THUS AN APPROPRIATE ANTIBIOTIC THERAPY WITH VANCOMYCIN AND EREMFAT WAS STARTED AND A WOUND REVISION TOOK PLACE ON (B)(6) 2018. (REMARK OF THE AUTHOR: THIS DATE DOES NOT MATCH THE INFORMATION IN THE RECEIVED DOCUMENTATION AND CAN BE ASSUMED TO BE A TYPO). - X-RAYS AND CT. PELVIS X-RAY TAKEN ON (B)(6) 2018: THE PELVIS OVERVIEW SHOWS TOTAL HIP PROSTHESES IMPLANTED IN THE LEFT AND RIGHT HIP . ON THE LEFT SIDE THE CLS SHELL IS LOOSE AND TIPPED TO A VERTICAL POSITION. IT SEEMS THAT A SEGMENT OF THE CLS SHELL IS SLIGHTLY MISALIGNED AS COMPARED WITH THE OTHERS. OSTEOLYTIC BONE CHANGES CAN BE SEEN IN THE EPIPHYSIS AND METAPHYSIS REGION OF THE FEMUR. - PELVIS CT TAKEN ON (B)(6)2018. THE CT SHOWS NO ADDITIONAL INFORMATION TO THE OBSERVATIONS MADE ON THE PELVIS X-RAY FROM (B)(6) 2018. SEVERAL X-RAYS TAKEN AFTER THE REVISION OF (B)(6) 2018 WERE RECEIVED. THESE X-RAYS ARE NOT FURTHER DISCUSSED AS THEY DO NOT CONTRIBUTE TO THE CURRENT INVESTIGATION. NOTE: THE SECOND REVISION SURGERY WHICH OCCURRED ON (B)(6) 2018 IS REPORTED UNDER (B)(4) (BFARM NUMBER (B)(4)). DEVICES ANALYSIS: - VISUAL EXAMINATION: ONE SEGMENT OF THE CLS SHELL IS FRACTURED. THE CRACK PROPAGATED FROM ONE HOLE ON THE END OF THE SLIT TO THE NEXT HOLE. IT SEEMS THAT THE FRACTURE OCCURRED FROM THE INSIDE TO THE OUTSIDE AND STARTED FROM ONE EDGE. SOME POLISHED AREAS CAN BE OBSERVED ON THE FRACTURE SURFACES . THE FRACTURE SURFACE ON THE SHELL SIDE WAS INVESTIGATED USING A SCANNING ELECTRON MICROSCOPE (SEM) TYPE JEOL JSM-6610 (EQ-ID: (B)(4) ). THE FRACTURE SURFACE EXHIBITS A FATIGUE STRUCTURE INCLUDING TYPICAL SECONDARY CRACKS. AREAS SHOWING RESIDUAL FRACTURE COULD NOT BE FOUND ON THE FRACTURE SURFACES. AS FAR AS VISIBLE NO DEFECTS THAT COULD HAVE TRIGGERED OR FAVORED THE FRACTURE COULD BE FOUND ON THE FRACTURE SURFACES. ON THE ANCHORING SIDE OF THE SHELL, THE THREE SEGMENTS OPPOSITE TO THE BROKEN SEGMENT SHOW SOME BONE ATTACHMENTS. ON THE BROKEN SEGMENT AND THE NEIGHBORING SEGMENTS POLISHED AREAS CAN BE OBSERVED ON THE ANCHORING SURFACE. ON THE INNER SIDE OF THE SHELL NUMEROUS SMALL LINE-SHAPED SHINY POLISHED AREAS CAN BE SEEN AROUND THE CENTER AND ON THE THREAD. ON THE FRACTURED SEGMENT POLISHED AREAS CAN BE SEEN ONLY ON THE THREAD. FINE AND COARSE SCRATCHES AS WELL AS INSTRUMENT MARKS CAN BE RECOGNIZED ON THE INNER AND ANCHORING SIDE OF THE SHELL. THESE CAN BE ATTRIBUTED TO THE REVISION SURGERY. THE ARTICULATION SURFACE OF THE CLS INSERT IS WORN TO AN OVAL. ON THE ENTIRE ARTICULATION SURFACE ONLY A SMALL AREA WHERE THE MACHINING LINES REMAINED RECOGNIZABLE CAN BE FOUND. THE WEAR IS ORIENTED TOWARDS THE EQUATOR REGION UNDER THE RIM. THE LATTER IS BENT OUTWARDS AND SHOWS SIGNS OF LAYER DELAMINATION. THE BENT AREA IS CRACKED ON BOTH SIDES. WITHIN THIS LOCATION THE OUTER EDGE OF THE RIM IS BROKEN OFF. ON THE ARTICULATION SURFACE A WHITE ROUGHENED REGION AND SIGNS OF LAYER DELAMINATION ARE VISIBLE IN THIS REGION. OPPOSITE TO IT, THE INSERT¿S RIM EXHIBITS AN APPROXIMATELY 20 MM LONG AREA WHEREBY HALF OF IT HAS A SMOOTH WORN AND THE OTHER HALF A ROUGHENED WHITISH APPEARANCE. THERE ARE ALSO SMALL METALLIC PARTICLES EMBEDDED IN THE POLYETHYLENE. ON THE ANCHORING SIDE OF THE INSERT BACKSIDE CHANGES CAN BE OBSERVED. THE CONTOUR OF THE SHELL IS INDENTED NON-SYMMETRICALLY ON THE POLAR REGION OF THE POLYETHYLENE. THE FRACTURE LINE OF THE SHELL¿S BROKEN OFF SEGMENT IS WELL VISIBLE. THERE ARE SEVERAL CRACKS IN THE POLAR REGION OF THE INSERT. THE THREAD STRUCTURE OF THE INSERT IS NOT ANYMORE IN ITS ORIGINAL CONDITION. THE DISTAL ORIGINAL NON-THREADED REGION REMAINED ONLY IN A SMALL AREA WHEREAS IN THE REST OF THIS REGION A THREAD STRUCTURE CAN BE RECOGNIZED. PARTS OF THE THREAD STRUCTURE ARE POLISHED AND WORN. IN WORN AREAS THE THREAD STRUCTURE APPEARS FLATTENED. SEVERAL METALLIC PARTICLES ARE EMBEDDED IN THE POLYETHYLENE. THE SULOX HEAD TAPER SHOWS THE COMMONLY OBSERVED METAL TRANSFER FROM THE STEM TAPER INDICATING A PROPER FIXATION OF THE HEAD ON THE STEM AND THE METAL TRACK PROBABLY FROM ITS REMOVAL. METALLIC SMEARING CAN BE NOTICED ON THE BOTTOM BEVEL OF THE HEAD AND SLIGHTLY ON THE ARTICULATION SURFACE. THIS DERIVED PROBABLY FROM THE REVISION SURGERY. - WEAR ESTIMATION: AS THE WORN AREA OF THE CLS INSERT IS ORIENTED TOWARDS THE EQUATOR UNDER THE RIM A 3D WEAR MEASUREMENT CANNOT BE PERFORMED. TO ESTIMATE THE ARTICULATION WEAR THE THICKNESS OF THE INSERT¿S RIM WAS CHECKED WITH A CALIPER (MITUTOYO, SAP ID (B)(4)) IN THE WORN AREA AND THE CORRESPONDING OPPOSITE AREA. THE DIFFERENCE BETWEEN THESE TWO VALUES WAS CALCULATED AND AMOUNTS TO APPROXIMATELY 3 MM WHICH WOULD RESULT IN AN APPROXIMATE WEAR RATE OF 0.16 MM/YEAR. SEMLITSCH ET AL. REPORTED THAT THE EXPECTED POLYETHYLENE WEAR RATE FOR CERAMIC HEADS (ALUMINUM OXIDE FOR DIAMETERS 28 AND 32MM AND ZIRCONIUM OXIDE FOR 22 MM) COMBINED WITH POLYETHYLENE CUPS IS 0.05 TO 0.15 MM/YEAR [1]. [1] SEMLITSCH M, WILLERT HG. CLINICAL WEAR BEHAVIOUR OF UHMW POLYETHYLENE CUPS PAIRED WITH METAL AND CERAMIC BALL HEADS IN COMPARISON TO METAL-ON-METAL PAIRINGS OF HIP JOINT REPLACEMENTS. PROC INST MECH ENG [H]. 1997; 211(73). CONCLUSION: ACCORDING TO THE RECEIVED INFORMATION, THE RETRIEVALS AT HAND WERE REVISED AFTER APPROXIMATELY 19 YEARS IN VIVO. THE ANAMNESIS SECTION OF THE RECEIVED DOCUMENTATION STATES THE PATIENT FELL AND HEARD A CRACKING SOUND FOUR MONTHS BEFORE REVISION. HE DID NOT GO TO THE DOCTOR AND SINCE THEN HE HAD PAIN IN THE LEFT HIP AND WALKING WAS POSSIBLE ONLY WITH THE HELP OF CRUTCHES. SHORTLY BEFORE REVISION THE PATIENT FELL OFF HIS BIKE ON HIS LEFT HIP AND WAS ADMITTED TO THE EMERGENCY ROOM. THE IMAGING PERFORMED BEFORE REVISION REVEALED A LOOSE ACETABULAR COMPONENT AND GRANULOMAS IN THE ACETABULUM AS WELL AS IN THE UPPER THIRD OF THE FEMUR AND IN THE TROCHANTER MAJOR. A REVISION OF CUP AND HEAD WAS PERFORMED. ONE OF THE SHELL¿S SEGMENTS IS FRACTURED. THE FRACTURE OCCURRED DUE TO FATIGUE. IT SEEMS THAT THE FRACTURE STARTED FROM THE INSIDE TO THE OUTSIDE AT ONE EDGE OF THE SEGMENT. AS FAR AS VISIBLE, NO DEFECTS THAT COULD HAVE TRIGGERED OR FAVORED THE FRACTURE COULD BE FOUND ON THE FRACTURE SURFACES. ON APPROXIMATELY ONE HALF OF THE SHELL¿S ANCHORING REGION SOME BONE ATTACHMENTS CAN BE SEEN. ON THE OTHER HALF OF THE SHELL INCLUDING THE BROKEN OFF SEGMENT SIGNS OF LOOSENING IN THE FORM OF POLISHED AREAS CAN BE RECOGNIZED. THE SMALL LINE-SHAPED SHINY POLISHED AREAS ON THE INNER SIDE OF THE SHELL AND THE SEVERAL PHENOMENA OBSERVED ON THE ANCHORING SIDE OF THE POLYETHYLENE INSERT INDICATE MICROMOTION BETWEEN BOTH PARTS AT LEAST FROM ONE POINT IN TIME. THE SEVERAL PHENOMENA OBSERVED ON THE ANCHORING SIDE OF THE INSERT ALSO POINT TO A CHANGE OF THE INSERT¿S POSITION IN THE SHELL. THE ARTICULATION SURFACE OF THE INSERT IS WORN TO AN OVAL AND ONLY A SMALL AREA WHERE THE MACHINING LINES REMAINED RECOGNIZABLE CAN BE FOUND. FURTHER THE INSERT¿S RIM EXHIBITS AN APPROXIMATELY 20 MM LONG AREA PARTIALLY WORN AND PARTIALLY OF A ROUGHENED WHITISH APPEARANCE. THIS AREA COULD HAVE DERIVED FROM IMPINGEMENT WITH THE STEM NECK. IT IS UNKNOWN IF THIS WAS ALREADY PRESENT BEFORE THE TIPPING OF THE CUP OR IS A CONCOMITANT OF IT. IT IS HYPOTHESIZED THAT THE IMPINGEMENT TRIGGERED THE CHANGE OF THE INSERT¿S POSITION IN THE SHELL PROBABLY AFTER THE FRACTURE OF THE SEGMENT. SEVERAL POSSIBLE SOURCES FOR POLYETHYLENE WEAR WERE FOUND DURING INVESTIGATION: ARTICULATION WEAR. WEAR DUE TO IMPINGEMENT. WEAR DERIVING FROM BACKSIDE CHANGES ON THE ANCHORING SIDE OF THE INSERT. POLYETHYLENE WEAR COULD BE A REASON FOR THE GRANULOMAS AS DESCRIBED IN THE SURGICAL NOTES OF REVISION. CRACKS, LAYER DELAMINATION AND WHITE ROUGHENED AREAS SEEN ON THE POLYETHYLENE INSERT POINT TO MATERIAL EMBRITTLEMENT DUE TO OXIDATION. THE X-RAY BEFORE THE REVISION SURGERY SHOWS THE CLS CUP LOOSE AND TIPPED TO A VERTICAL POSITION. IN THIS POSITION THE HEAD COULD ARTICULATE AGAINST THE EQUATOR REGION OF THE INSERT¿S ARTICULATION SURFACE. AS THE COMPLETE X-RAY FOLLOW-UP IS NOT AT HAND IT STAYS UNKNOWN WHICH OF THE DESCRIBED PHENOMENA OCCURRED FIRST AND WHICH POSSIBLY TRIGGERED THE OTHER AS WELL AS IF THE PATIENT¿S FALL HAD AN INFLUENCE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO IMPLANT FRACTURE.
NO EVENT UPDATE.
UNIQUE IDENTIFIER (UDI) #: (B)(4). THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE NOT REVIEWED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE, AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO LOOSENING OF CUP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 613661 | CLS SPOTORNO, EXPANSION SHELL, UNCEMENTED, 56 | CLS ACETABULAR COMPONENT (MODIFICATION) | LZO | ZIMMER GMBH | N/A | 96557508 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |