LOR SHELL 64 X 76
Report
- Report Number
- 0009613350-2019-00018
- Event Type
- Injury
- Date Received
- January 11, 2019
- Date of Event
- December 20, 2018
- Report Date
- August 13, 2019
- Manufacturer
- ZIMMER GMBH
- Product Code
- LZO
- UDI-DI
- 90213100001
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- 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: A2 - H2 , CORRECTION: A3 - B4 - E1 - G4 - G7 - H10. 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).
THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY INVESTIGATION RESULT. DHR REVIEW: THE DHR CHECK COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE AND NOT LEGIBLE ON THE EXPLANT. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: IMPLANT FRACTURE EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A HIP PROTHESIS IN 2000 AND WAS REVISED ON (B)(6) 2018 DUE TO A FRACTURE OF THE LOR CUP. MOREOVER, THE REVISION REPORT MENTIONS METALLOSIS. REVIEW OF RECEIVED DATA: REVISION REPORT, (B)(6) 2018 DIAGNOSIS: FRACTURE OF THE LOR CUP WITH STATUS AFTER ¿ HIP TOTAL ENDOPROSTHESIS IN 2000. ¿ ACETABULAR FRACTURE AFTER MOTORBIKE ACCIDENT 50 YEARS AGO INDICATION: FRACTURE OF THE LOR CUP. DUE TO IMMOBILIZING COMPLAINTS AND SENSORY DISTURBANCES ON THE BUTTOCKS, GENITAL REGION AND BLADDER EMPTYING DISTURBANCE, THE INDICATION FOR CHANGING THE CUP IS GIVEN. THE ISCHIADICUS NERVE IS TO BE DISPLAYED. THE SKIN INCISION IS PERFORMED THROUGH THE PRE-EXISTING SCAR. AFTER A LONGITUDINAL SPLITTING OF THE FASCIA LATA VENTRAL OF THE GLUTEUS MAXIMUS, SEROUS FLUID DRAINS. ADDITIONALLY, SOME BLOODY TINGED, SLIGHTLY CLOUDY LIQUID EMPTIES. THE JOINT IS DISLOCATED AND THE HEAD IS REMOVED. THE STEM IS FIX. A RELEASE IS PERFORMED IN THE AREA OF THE PROXIMAL FEMUR. RESECTION OF HETEROTOPIC OSSIFICATIONS ALONG THE INSIDE OF THE ABDUCTORS IS PERFORMED WITH COLLECTION OF TISSUE SAMPLES FOR BACTERIOLOGICAL EXAMINATION. METALOSIS IS VISIBLE. THE CUP IS EXPOSED. IT IS BROKEN. THE CRANIAL PART OF THE SHELL CAN BE REMOVED BY HAND. TWO LOOSE SCREWS ARE ALSO REMOVED. THE CAUDAL PART OF THE SHELL IS STILL FIRMLY FIXED BY TWO SCREWS. THE LATTER ARE THEN REMOVED. THE REMAINING BONE BED IS PARTLY NECROTIC, PARTLY INTERSPERSED WITH METALOSIS. THE CRANIAL PORTION IS NO LONGER SUPPORTIVE. THE AIM IS, AS ALREADY PLANNED, TO PLACE THE NEW CUP IN THE ORIGINAL ACETABULUM. THE NECESSARY DISTALIZATION IS SMALL AND THE LENGTH OF THE SCIATIC NERVE IS GIVEN AS IT CORRESPONDS TO AN ORIGINAL CONDITION. THE FURTHER PROCEDURE DESCRIBES THE IMPLANTATION OF THE NEW COMPONENTS AND DID NOT INCLUDE INFORMATION THAT WOULD CONTRIBUTE TO THE CASE. X-RAYS A PELVIS OVERVIEW AND A RIGHT HIP IN AXIAL VIEW WERE TAKEN ON (B)(6) 2018. IT IS CLEARLY VISIBLE THAT THE LOR SHELL IS FRACTURED. ON THE AP X-RAY THE CRANIAL FRACTURE PART OF THE SHELL SEEMS TO BE DISLOCATED AND / OR TIPPED FROM ITS ORIGINAL IMPLANTATED POSITION. CHANGES TO THE BONE CANNOT BE COMMENTED AS THERE IS NO OTHER X-RAY FOR COMPARISON. THE OTHER TWO X-RAYS ARE NOT DATED. BASED ON THE IMPLANTED COMPONENTS IT IS ASSUMED THAT THEY WERE TAKEN AFTER THE REVISION SURGERY. THEREFORE, THEY ARE NOT INCLUDED IN THE REPORT. DEVICE ANALYSIS: VISUAL EXAMINATION THE LOR SHELL IS FRACTURED DIAGONALLY INTO TWO PIECES (CRANIAL AND CAUDAL). ON THE ANCHORING SIDE OF THE LOR SHELL SLIGHT REMAINS OF BONE ATTACHMENT CAN BE RECOGNIZED ON THE CAUDAL FRACTURE PART. POLISHED AREAS ON THE ANCHORING SURFACE CAN BE SEEN PREDOMINANTLY ON CRANIAL FRACTURE PART. ON THE INNER SIDE OF THE SHELL NUMEROUS POLISHED AREAS CONSISTING OF A PATTERN OF SMALL LINES AND DOTS CAN BE SEEN ON THE BOTTOM LEDGE, IN THE SPHERICAL AREAS AS WELL AS ALONG THE CRANIAL FRACTURE PART'S EDGE. FINE AND COARSE SCRATCHES AS WELL AS INSTRUMENT MARKS CAN BE RECOGNIZED ON THE SHELL'S RIM WHICH CAN LIKELY BE ATTRIBUTED TO THE REVISION SURGERY. SOME INDENTS AND / OR WEAR CAN ALSO BE OBSERVED IN SOME OF THE SCREW HOLES. ADDITIONALLY, DRILL MARKS CAN BE SEEN IN MORE SCREWS HOLES THAN SCREWS RECEIVED. IN ONE AREA NEXT TO A SCREW HOLE, DAMAGE CAN BE FOUND ACROSS THE FRACTURE LINE. SOME OF THE FRACTURE SURFACES ARE PARTIALLY DAMAGED AND / OR POLISHED. BASED ON A VISUAL EXAMINATION IT CANNOT BE SAID IF THE FRACTURE OCCURRED FROM THE INSIDE OR THE OUTSIDE. THE FRACTURE SURFACES ON THE SHELL'S CAUDAL FRACTURE PART SHOW MORE POLISHING. THEREFORE THE FRACTURE SURFACES ON THE CRANIAL FRACTURE PART WERE INVESTIGATED USING A SCANNING ELECTRON MICROSCOPE (SEM) TYPE JEOL JSM-6610 (EQ-ID: WNT-03-RSR-541-151103). THE FRACTURE SURFACES EXHIBITS A FATIGUE STRUCTURE INCLUDING TYPICAL SECONDARY CRACKS. IT WAS NOT POSSIBLE TO DETERMINE THE FRACTURE ORIGIN ON THE FRACTURE SURFACES. AS FAR AS VISIBLE NO DEFECTS THAT COULD HAVE TRIGGERED OR FAVORED THE FRACTURE COULD BE FOUND ON THE INVESTIGATED FRACTURE SURFACES. SIX SCREWS WERE RECEIVED IN DIFFERENT LENGTHS. ONE OF THE SCREWS IS FRACTURED BELOW THE SCREW HEAD. THE LATTER IS MISSING. THE REMAINING SCREWS SHOW METAL WEAR AND DAMAGE IN THE AREA OF THE HEADS. THE LOR INSERT SEEMS TO BE SLIGHTLY DEFORMED, IS PARTIALLY YELLOWISH DISCOLORED AND SHOWS SOME REMOVAL DAMAGE. THE METAL BACK AND THE POLYETHYLENE PART ARE SEPARATED. ON THE ARTICULATION SIDE, THE RIM SHOWS SIGNS OF LAYER DELAMINATION ALONG THE EDGE AND SOME SMALL AREAS WITH POLISHING AND ABRASION. THERE IS POSSIBLY SOME BODY FLUID VISIBLE THAT IS TRAPPED UNDERNEATH THE SURFACE LAYER OF THE ABOVE MENTIONED DELAMINATION. THE ARTICULATION SURFACE OF THE LOR INSERT HAS ON OVAL APPEARANCE POSSIBLY DUE TO WEAR. UNDER CERTAIN LIGHT CONDITION THE BORDERLINE OF THE WEAR ZONE IS CLEARLY VISIBLE. THE WEAR IS ORIENTED TOWARDS THE EQUATOR REGION UNDER THE RIM. CLOSER INSPECTION OF THE ARTICULATION SURFACE USING A MICROSCOPE (LEICA MZ16 A, EQ-ID: WNT-03-RSR-540-151663) SHOWED MANUFACTURING PATTERN IN THE UNLOADED AREA AND SLIGHT SCRATCHES IN THE LOADED AREA. A FEW METAL PARTICLES ARE ALSO EMBEDDED INTO THE ARTICULATION SURFACE. THE BACKSIDE OF THE INSERT SHOWS LARGER AREAS OF ABRASION AND THE CONTOUR OF THE SHELL HAS BEEN IMPRINTED IN THE POLYETHYLENE. CLOSER INSPECTION OF THE BACKSIDE WITH A BINOCULAR (WILD M38, HEERBRUGG SWITZERLAND, EQ-ID: WNT-03-RSR-540-161187) WITH A MAGNIFICATION UP TO 40X REVEALED BACKSIDE CHANGES. THE CERAMIC HEAD TAPER SHOWS THE COMMONLY OBSERVED METAL TRANSFER FROM THE CONTACT WITH THE STEM TAPER AND THE REMOVAL.. METALLIC SMEARING CAN BE NOTICED ON THE BOTTOM BEVEL OF THE HEAD AND SLIGHTLY ON THE ARTICULATION SURFACE. THESE DERIVED PROBABLY FROM THE CONTACT TO A METALLIC PART (E.G. COMPONENTS, INSTRUMENT) EITHER AFTER THE FRACTURE AND / OR DURING THE REVISION SURGERY. REVIEW OF PRODUCT DOCUMENTATION: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. CONCLUSION: AFTER APPROXIMATELY 18 YEARS IN VIVO THE LOR CUP WAS REVISED DUE TO A FRACTURE OF THE LOR SHELL. THE LOR SHELL IS FRACTURED DIAGONALLY INTO TWO PIECES (CRANIAL AND CAUDAL). THE INVESTIGATION SHOWED 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 INVESTIGATED BY SEM. ON THE ANCHORING SIDE OF THE LOR SHELL SLIGHT REMAINS OF BONE ATTACHMENT CAN BE RECOGNIZED ON THE CAUDAL FRACTURE PART WHILE POLISHED AREAS CAN BE SEEN PREDOMINANTLY ON CRANIAL FRACTURE PART. THIS COULD INDICATE LOOSENING IN THE CRANIAL HALF OF THE SHELL. ADDITIONALLY, THE REVISION SURGERY REPORT STATES THAT THE REMAINING ACETABULAR BONE BED IS PARTLY NECROTIC, PARTLY INTERSPERSED WITH METALOSIS AND THAT THE CRANIAL PORTION IS NO LONGER SUPPORTIVE. IT CANNOT BE DETERMINED IF THIS SITUATION OCCURRED BEFORE OR AFTER THE FRACTURE. ON THE INNER SIDE OF THE SHELL NUMEROUS POLISHED AREAS CONSISTING OF A PATTERN OF SMALL LINES AND DOTS CAN BE SEEN ON THE BOTTOM LEDGE. ADDITIONALLY, THE INSERT SHOWS BACKSIDE CHANGES. BOTH PHENOMENA POINT TO MICROMOTIONS BETWEEN THE INSERT AND THE SHELL. INDENTS, WEAR, DRILL MARKS AND DAMAGE WERE OBSERVED IN AND AROUND THE SCREWS HOLES. THESE COULD HAVE DERIVED FROM THE SCREW ITSELF, INDICATING MOVEMENT BETWEEN THE SHELL AND THE SCREWS AND / OR COULD HAVE MADE BY INSTRUMENTS DURING IMPLANTATION. HOWEVER, IT REMAINS UNKNOWN IF THESE OBSERVATIONS OCCURRED BEFORE OR AFTER THE FRACTURE AND IF AND TO WHAT EXTEND THEY MIGHT HAVE INFLUENCED THE FRACTURE. THE X-RAY BEFORE THE REVISION SURGERY SHOWS THE LOR SHELL FRACTURED WHILE THE CRANIAL FRACTURE PART SEEMS TO BE DISLOCATED AND / OR TIPPED. IN THIS POSITION THE INSERT WAS NO LONGER RESTRICTED. THEREFORE AND BASED ON THE POSITION AND THE APPEARANCE OF THE LARGE ABRASIONS SEEN ON THE BACKSIDE OF THE INSERT IT IS ASSUMED THAT THESE OCCURRED AFTER THE FRACTURE DUE TO THE REPETITIVE CONTACT TO THE SHARP EDGES OF THE SHELL'S FRACTURE SURFACES. THE LOR INSERT SEEMS TO BE SLIGHTLY DEFORMED AND SHOWS SIGNS OF LAYER DELAMINATION. THE LATTER POINTS TO MATERIAL EMBRITTLEMENT DUE TO OXIDATION. THE DEFORMATION MOST LIKELY DERIVED FROM A CLEANING AND / OR STERILIZATION PROCEDURE (E.G. THERMAL DISINFECTOR, AUTOCLAVING) OUTSIDE ZIMMER BIOMET. THE WEAR ON THE INSERT¿S ARTICULATION SURFACE IS ORIENTED TOWARDS THE EQUATOR REGION UNDER THE RIM. THIS COULD BE AN INDICATION OF RIM LOADING WHICH MIGHT HAVE LED TO AN INCREASED LOAD IN THE CRANIAL REGION OF THE LOR CUP. WITH THE INVESTIGATIONS PERFORMED AND THE RECEIVED DOCUMENTATION A REASON FOR THE FRACTURE COULD NOT BE IDENTIFIED. POSSIBLE FACTORS THAT MIGHT HAVE INFLUENCED THE FRACTURE COULD BE: LOOSENING IN THE CRANIAL HALF OF THE SHELL, CHANGES TO THE ACETABULAR BONE , INDENTS, WEAR, DRILL MARKS AND DAMAGE OBSERVED IN AND AROUND THE SCREWS HOLES. HOWEVER, IT REMAINS UNKNOWN IF THESE PHENOMENA OCCURRED BEFORE OR AFTER THE FRACTURE AND IN WHAT ORDER THEY OCCURRED. ADDITIONALLY, WITH NO COMPLETE X-RAY FOLLOW UP AND MISSING INFORMATION ABOUT THE PATIENT¿S MEDICAL HISTORY IT REMAINS UNKNOWN IF ANY PATIENT FACTORS OR OTHER FACTORS COULD HAVE CONTRIBUTED TO THE SHELL FRACTURE. 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).
THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. 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).
PLEASE REFER TO REPORT 0009613350-2019-00018.
PLEASE REFER TO REPORT 0009613350-2019-00018
IN ADDITION TO THE REPORT 0009613350 - 2019 - 00018, DURING REVISION TURBID SEROUS FLUID AND HETEROTOPIC OSSIFICATION IN THE INNER SIDE OF THE ABDUCTORS WAS FOUND. PART OF THE CUP COULD BE EASILY REMOVED WITH THE HAND; TWO LOOSE SCREWS WERE RETRIEVED. NECROTIC TISSUE WAS FOUND. OP REPORT MENTIONS METALLOSIS. DEBRIDEMENT WAS PERFORMED.
CONCOMITANT MEDICAL PRODUCTS: INSERT HIP IMPL WIN GEN, CATALOG NO# UNKNOWN, LOT NO# UNKNOWN. HEAD HIP IMPL WIN GEN, CATALOG NO# UNKNOWN, LOT NO# UNKNOWN. THERAPY DATE: (B)(6) 2018. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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).
PATIENT WAS IMPLANTED ON UNKNOWN SIDE AND UNDERWENT REVISION DUE TO IMPLANT FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 34172 | LOR SHELL 64 X 76 | LOR SHELL | LZO | ZIMMER GMBH | N/A | UNKNOWN | 90213100001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |