CLS EXPANSION CUP 48 MM
Report
- Report Number
- 0009613350-2019-00087
- Event Type
- Injury
- Date Received
- February 25, 2019
- Date of Event
- February 1, 2019
- Report Date
- October 21, 2019
- Manufacturer
- ZIMMER GMBH
- Product Code
- LZO
- PMA / PMN Number
- K953688
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
ITEM NAME: CLS INSERT 48/28, ITEM#: 682848, LOT#: 95387398, ITEM NAME: BIOLOX FORTE, HEAD, ITEM#: 122805, LOT#: UNKNOWN. DHR-REVIEW: REF#: (B)(4), LOT#: 95392433, YIELD: 52, DELIVERED: 52. 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: MEDICAL : REVISION DUE TO IMPLANT FRACTURE. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT HAD A REVISION ON (B)(6) 2019 DUE TO A BROKEN SPOTORNO CUP ON THE RIGHT SIDE. THE PRIMARY IMPLANTATION DATE IS ON (B)(6) 1996. REVIEW OF RECEIVED DATA: AN X-RAY DISPLAYED ON A LIGHTBOX WAS PHOTOGRAPHED AND RECEIVED AND THEREFORE ITS QUALITY IS LIMITED. THE UNDATED X-RAY SHOWS THE RIGHT HIP IN AP VIEW. IT IS CLEARLY VISIBLE THAT AT LEAST ONE SEGMENT OF THE CLS SHELL IS FRACTURED. IT SEEMS THAT THE HEAD IS IN CONTACT WITH THE FRAGMENT. THE CENTER OF THE HEAD DOES NOT COINCIDE WITH THE CENTER OF THE CUP. THE LATTER APPEARS TO BE IN A RATHER VERTICAL POSITION. SURGERY REPORT:ON (B)(6) 1996. DIAGNOSIS: ADVANCED COXARTHOSIS RIGHT. SURGERY: IMPLANTATION OF AN UNCEMENTED HIP PROSTHESIS INCLUDING A BICONTACT® STEM SIZE 11, A CLS CUP SIZE 48 AND A HEAD Ø28 SHORT NECK. THE PATIENT IS IN THE SUPINE POSITION; A SKIN INCISION IS FIRST MADE ON THE OUTSIDE OF THE RIGHT THIGH. THE SUBCUTANEOUS TISSUE IS TRANSECTED AND HEMOSTASIS IS PERFORMED. THE FASCIA LATA AND THEN THE VASTUS LATERALIS AND THEIR MUSCLES ATTACHED AT THE GREATER TROCHANTER ARE SPLIT. THE HIP JOINT CAPSULE IS EXPOSED AND OPENED. THE FEMORAL NECK IS SHOWN AND THE FEMORAL HEAD IS DISLOCATED. DISTINCT OSTEOPHYTE FORMATIONS ARE CHISELED ON THE EDGE OF THE ACETABULUM. THEN THE ACETABULUM IS PREPARED UP TO THE DIAMETER OF 48 MM. THE APPROPRIATE SHELL IS PLACED IN CORRECT POSITION AND THE INSERT IS SCREWED INTO IT. THE PROXIMAL FEMUR IS SHOWN. THE RESECTION PLANE IS THEN RE-RESECTED WITH THE SAW AT A CORRESPONDING ANGLE. CORRESPONDING RASPS ARE USED UP TO SIZE 11. A BICONTACT® STEM (AESCULAP) IS IMPLANTED, THE HEAD IS MOUNTED AND THE JOINT REDUCED. IT SHOWS A GOOD MOBILITY WITHOUT DISLOCATION TENDENCY. A REDON DRAINAGE IS PLACED AND THE WOUND IS CLOSED LAYER-BY-LAYER. DEVICES ANALYSIS: VISUAL EXAMINATION: ONE SEGMENT OF THE CLS SHELL IS FRACTURED. THE CRACK PROPAGATED FROM ONE SLIT TO THE OTHER SLIT IN THE AREA OF THE ROUGH BLASTED SURFACE. THE FRACTURE SURFACES ARE PARTIALLY POLISHED AND WORN. THE ANCHORING SURFACE OF THE SHELL SHOWS NO BONE ATTACHMENTS BUT POLISHED AREAS. THE POLISHING IS MORE PRONOUNCED IN THE POLE REGION. ON THE INNER SIDE OF THE SHELL NUMEROUS SMALL DOT-SHAPED SHINY POLISHED AREAS CAN BE SEEN AROUND THE CENTER IN THE HALF OF THE FRACTURED SEGMENT. THE THREAD OF THE SHELL SEEMS TO BE PARTIALLY WORN AND SHOWS SOME AREAS WITH POLISHING. ON THE FRACTURED SEGMENT A POLISHED, SPHERICAL-SHAPED WEAR ZONE CAN BE SEEN ACROSS THE THREAD. THE CLS INSERT IS PARTIALLY SLIGHTLY YELLOWISH DISCOLORED. THE ARTICULATION SURFACE IS WORN TO AN OVAL AND SHOWS SOME DAMAGE IN FORM OF NICKS AND INDENTS MOST LIKELY FROM THE REVISION SURGERY. THE BORDERLINE BETWEEN THE LOADED AND THE UNLOADED AREA IS SLIGHTLY VISIBLE UNDER CERTAIN LIGHT CONDITION. THE WEAR IS ORIENTED TOWARDS THE EQUATOR REGION UNDER THE RIM. THE LATTER SHOWS SIGNS OF LAYER DELAMINATION AND SOME CUTS AND DAMAGE THAT MOST LIKELY OCCURRED DURING REVISION SURGERY. SOME CRACKS AND SIGNS OF LAYER DELAMINATION CAN BE OBSERVED IN ONE HALF OF THE ARTICULATION SURFACE BELOW THE RIM. IN ONE AREA A PART OF THE RIM IS BROKEN OFF. THERE IS A MIXTURE OF GREY DISCOLORATION AND SOME BODY FLUID VISIBLE THAT IS TRAPPED UNDERNEATH THE SURFACE LAYER OF THE ABOVE MENTIONED DELAMINATION. CLOSER INVESTIGATION OF THE ARTICULATION SURFACE WITH THE LOW POWER MICROSCOPE REVEALED MOSTLY SLIGHT SCRATCHES IN THE LOADED AREA WHILE IN THE UNLOADED AREA IN SOME ZONES MACHINING LINES CAN BE RECOGNIZED. ADDITIONALLY, TINY POLISHED METALLIC PARTICLES ARE EMBEDDED IN THE POLYETHYLENE. THE ANCHORING SIDE OF THE INSERT MIRRORS THE CONTOUR OF THE SHELL. IMPRINTS OF THE HOLES AT THE END OF THE SLITS CAN BE RECOGNIZED IN ONE HALF. IN THE SAME AREA AN INDENTATION OF THE FRACTURED SEGMENT CAN BE SEEN. UNDERNEATH THE LATTER, THE MATERIAL SEEMS TO BE GREYISH STAINED. TWO SMALL, POLISHED AND METALLIC PIECES ARE EMBEDDED IN THE POLYETHYLENE ABOVE THE INDENTATION. THERE ARE SEVERAL CRACKS LOCATED IN ONE AREA IN THE POLAR REGION OF THE INSERT AS WELL AS ALONG THE EQUATOR. CLOSER INSPECTION OF THE ANCHORING SIDE WITH THE LOW POWER MICROSCOPE REVEALED BACKSIDE CHANGES AROUND THE IMPRINTS. THE IMPRINTS OF THE HOLES EXHIBIT A MIXTURE OF ABRASION AND MACHINING LINES. THE AREA OF THE BACKSIDE CHANGES CORRESPONDS TO THE LOADED AREA OF THE ARTICULATION SIDE. ON THE REMAINING SURFACE MACHINING LINES ARE VISIBLE. THE CERAMIC HEAD TAPER SHOWS COMMONLY OBSERVED METAL TRANSFER FROM THE CONTACT WITH THE STEM TAPER AND ITS REMOVAL. A LARGE AREA OF METALLIC SMEARING CAN BE SEEN AT THE HEIGHT OF THE EQUATOR. ADDITIONALLY SOME SLIGHT METALLIC SMEARING IN FORM OF DOTS AND LINES CAN BE NOTICED ON THE BOTTOM BEVEL OF THE HEAD AS WELL AS ON THE ARTICULATION SURFACE. SCANNING ELECTRON MICROSCOPE (SEM): THE FRACTURE SURFACE ON THE SHELL SIDE IS ALMOST COMPLETELY WORN. THEREFORE, THE FRACTURE SURFACE ON THE FRACTURED SEGMENT WAS INVESTIGATED USING A SEM. THE FRACTURE SURFACE IS WORN AS WELL AND SHOWS ORGANIC DEPOSITS. INDIVIDUAL AREAS EXHIBIT A FATIGUE STRUCTURE. AREAS SHOWING RESIDUAL FRACTURE AND THE FRACTURE ORIGIN 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. WEAR ESTIMATION: DUE TO THE INDENTATION OF THE FRACTURED SEGMENT ON THE CLS INSERT, IT WAS NOT POSSIBLE TO MEASURE THE WEAR USING A MOLD AND / OR 3D WEAR MEASUREMENT. TO ESTIMATE THE ARTICULATION WEAR THE THICKNESS OF THE INSERT WAS CHECKED WITH A GAUGE IN THE WORN AREA NEXT TO THE INDENTATION AND IN THE UNLOADED AREA. THE DIFFERENCE BETWEEN THESE TWO VALUES WAS CALCULATED AND AMOUNTS TO APPROXIMATELY 1.6 MM WHICH WOULD RESULT IN AN APPROXIMATE WEAR RATE OF 0.07 MM/YEAR. IT HAS TO BE ASSUMED THAT THE THICKNESS FOR THE WORN AREA COULD NOT BE MEASURED AT THE THINNEST POINT DUE TO THE INDENTATION. THEREFORE, THE WEAR VALUE FOR THE INSERT INDICATED ABOVE DOES NOT REFLECT THE TRUE AMOUNT OF WEAR. SEMLITSCH ET AL. REPORTED THAT THE EXPECTED POLYETHYLENE WEAR RATE FOR CERAMIC HEADS (ALUMINUM OXIDE FOR DIAMETERS 28 AND 32 MM AND ZIRCONIUM OXIDE FOR 22 MM) COMBINED WITH POLYETHYLENE CUPS IS 0.05 TO 0.15 MM/YEAR. REVIEW OF PRODUCT DOCUMENTATION: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. THE COMPATIBILITY CHECK WAS PERFORMED FROM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. SURGICAL TECHNIQUE: THE DEVICES WERE IMPLANTED IN 1996. THE IN VIVO TIME WAS MORE THAN 22 YEARS. THIS VERY LONG IN VIVO TIME IS A SIGN THAT THE IMPLANTED DEVICES PERFORMED VERY GOOD ALL OVER THE YEARS. THEREFORE, A ISSUE WITH THE SURGICAL TECHNIQUE CAN BE EXCLUDED. CONCLUSION SUMMARY: THE RETRIEVALS AT HAND WERE REVISED AFTER APPROXIMATELY 22 YEARS AND 11 MONTHS IN VIVO DUE TO A FRACTURE OF THE CLS SHELL. ON THE UNDATED X-RAY AND THE RETRIEVAL AT HAND ONE OF THE SHELL¿S SEGMENTS IS FRACTURED. THE SEM INVESTIGATION OF THE FRACTURE SURFACE REVEALED THAT THE FRACTURE OCCURRED DUE TO FATIGUE. AS FAR AS VISIBLE, NO DEFECTS THAT COULD HAVE TRIGGERED OR FAVORED THE FRACTURE COULD BE FOUND ON THE FRACTURE SURFACES. NO BONE ATTACHMENTS COULD BE OBSERVED ON THE ANCHORING SIDE OF THE CLS SHELL. INSTEAD 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 BACKSIDE CHANGES OBSERVED ON THE POLYETHYLENE INSERT INDICATE MICROMOTION BETWEEN BOTH PARTS AT LEAST FROM ONE POINT IN TIME. THE ARTICULATION SURFACE OF THE INSERT IS WORN TO AN OVAL. FURTHER THE INSERT EXHIBITS CRACKS AND LAYER DELAMINATION WHICH POINTS TO MATERIAL EMBRITTLEMENT DUE TO OXIDATION. THE METALLIC PIECES EMBEDDED IN THE POLYETHYLENE ARE CONCOMITANTS OF THE FRACTURE OF THE SEGMENT. BASED ON THE RETRIEVALS AT HAND AND WITHOUT A COMPLETE X-RAY FOLLOW-UP IT IS NOT POSSIBLE TO RECONSTRUCT THE SEQUENCE OF EVENTS LEADING TO THE FRACTURE OF THE CLS SHELL. AS FURTHER CLINICAL INFORMATION IS NOT AVAILABLE (SURGICAL REPORTS OF REVISION, PATIENT¿S MEDICAL HISTORY ETC.) ANY INFLUENCING FACTORS THAT MAY RESULT FROM IT REMAIN UNKNOWN. IT CAN ONLY BE HYPOTHESIZED THAT AT ONE POINT IN TIME THE CLS CUP BECAME PARTIALLY LOOSE, WHICH PROBABLY LED TO THE FRACTURE OF THE SEGMENT. IN THE FURTHER COURSE THE CUP POSSIBLY CHANGED ITS POSITION. IN THIS POSITION THE HEAD COULD ARTICULATE AGAINST THE FRACTURED SEGMENT LEADING TO THE WEAR ZONE ON THE FRACTURED SEGMENT AND THE LARGE METALLIC SMEARING ON THE HEAD. AS THE COMPLETE X-RAY FOLLOW-UP IS NOT AT HAND IT STAYS UNKNOWN AT WHAT POINT IN TIME THE DESCRIBED PHENOMENA OCCURRED. THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). 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).
INVESTIGATION RESULTS ARE NOW AVAILABLE.
CONCOMITANT MEDICAL PRODUCT: ZIMMER CLS INSERT 48/28 ITEM # UNKNOWN; LOT # UNKNOWN. THE MANUFACTURER DID NOT RECEIVE THE DEVICE YET, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. X-RAY AND SURGICAL IMPLANTATION REPORT WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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 HAD A REVISION ON (B)(6) 2019 DUE TO A BROKEN SPOTORNO CUP ON THE RIGHT SIDE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 158514 | CLS EXPANSION CUP 48 MM | CLS ACETABULAR COMPONENT (MODIFICATION) | LZO | ZIMMER GMBH | N/A | 95392433 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |