NV GXL LINER LIPPED 36MM ID GROUP 2
Report
- Report Number
- 1038671-2022-01378
- Event Type
- Injury
- Date Received
- November 1, 2022
- Date of Event
- October 7, 2022
- Report Date
- March 25, 2026
- Manufacturer
- EXACTECH, INC.
- Product Code
- JDI
- UDI-DI
- 10885862207036
- PMA / PMN Number
- K121392
- Removal / Correction Number
- Z-1732-2022
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE PAIN AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY DUE TO PATIENT RELATED CONDITIONS. CONCOMITANT DEVICE(S): (B)(4) 01-030-01-0552 - ALT CUP CLSTR G5 SZ 52. (B)(4) 01-030-01-0552 - ALT CUP CLSTR G5 SZ 52. (B)(4) 170-36-07 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +7MM. (B)(4) 188-01-10 - WEDGE PLASMA X/O SZ 10.
SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (D1) BRAND NAME: NV GXL LINER LIPPED 36MM ID GROUP 2, (D4) CATALOG NUMBER: 132-36-52, SERIAL NUMBER: (B)(6), EXPIRATION DATE: 16-APR-2022, UNIQUE, IDENTIFIER (UDI) #: (B)(4). (D6A) IF IMPLANTED, GIVE DATE: (B)(6) 2017. (D6B) IF EXPLANTED, GIVE DATE: (B)(6) 2021. (G3) DATE RECEIVED BY MANUFACTURER: 15-MAR-2023. (G4) PMA/510(K)NUMBER: K121392. (H4) DEVICE MANUFACTURE DATE: 18-APR-2017.
ADDITIONAL INFORMATION: B1, B5, B6, D8, H6 MEDICAL DEVICE PROBLEM CODE, H7, & H9 ADDITIONAL INFORMATION PROVIDED HAS CAUSED A CHANGE IN THE FAILURE MODE AND REQUIRES A NEW INVESTIGATION. PENDING INVESTIGATION CORRECTION D10. 132-36-52 - NV GXL LINER LIPPED 36MM ID GROUP 2; 4854468 170-36-07 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +7MM; 4716390 186-01-52 - INTEGRIP CC, CLUSTER 52MM, G2; 4973505 188-01-09 - WEDGE PLASMA X/O SZ 9; 4509885.
H3: INVESTIGATION RESULTS - THE MOST LIKELY CAUSE FOR THE REVISION REPORTED DUE TO EARLY PROSTHESIS WEAR IS A COMBINATION OF THE RISK FACTORS. A NUMBER OF VARIABLES INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS (FITNESS FOR SURGERY, BIOMECHANICS, ACTIVITY LEVEL AND LOCAL TISSUE OXIDATION POTENTIAL) COULD HAVE ALL CONTRIBUTED TO THE INCREASED TREND IN WEAR/OSTEOLYSIS RELATED COMPLAINTS. THE PROSTHESIS WEAR WAS NOT ABLE TO BE CONFIRMED FROM THE PROVIDED EXPLANTED DEVICES.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B1, B5, D8, G1, G4, H6 - HEALTH EFFECT - CLINICAL CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS, H7 AND H11. THERE IS NO EVIDENCE OF GAPS BETWEEN THE FEMORAL HEAD AND THE LINER, WHICH SUGGESTS THAT THE GXL LINER IS NOT WORN. A NUMBER OF VARIABLES INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS (FITNESS FOR SURGERY, BIOMECHANICS, ACTIVITY LEVEL AND LOCAL TISSUE OXIDATION POTENTIAL) COULD HAVE ALL CONTRIBUTED TO THE INCREASED TREND IN WEAR/OSTEOLYSIS RELATED COMPLAINTS. THE PROSTHESIS WEAR WAS NOT ABLE TO BE CONFIRMED FROM THE PROVIDED EXPLANTED DEVICES IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.
AS REPORTED, APPROXIMATELY 1.5 YEARS POST OP THE INITIAL TOTAL HIP ARTHROPLASTY, THIS 67 Y/O MALE PATIENT WAS REVISED DUE TO PAIN. THE SURGEON TOOK THE PATIENT TO SURGERY WHERE HE REVISED THE GXL LINER EXTENDED COVERAGE AND A +7 36MM HEAD. HE REVISED IT TO A XLE 36 MM LINER FACE CHANGING +5 LATERALIZED. HE USED A STEM ADAPTER +7 WITH A BIOLOGICS DELTA 36 HEAD. REPORTED EVENT IS NOT RELATED TO THE BREAKAGE OF A DEVICE AND DID NOT LEAD TO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE WAS RETURNED. NO ADDITIONAL INFORMATION.
ADDITIONAL INFORMATION RECEIVED VIA THE LEGAL DEPARTMENT: REVISION OPERATIVE REPORT FOR (B)(6) 2022. PREOPERATIVE DIAGNOSIS: FAILED RIGHT TOTAL HIP POLYETHYLENE DUE TO RECALL. OPERATIVE FINDINGS: THERE WAS FOUND TO BE A CLEAN WOUND WITH CLEAR SYNOVIAL JOINT FLUID. THERE WAS VISIBLE WEAR OF THE ACETABULAR POLYETHYLENE LINER. THERE WAS FOUND TO BE A WELL-FIXED ACETABULAR COMPONENT AND A WELL-FIXED FEMORAL COMPONENT. A LATERAL LINER WAS UTILIZED. CLINICAL HISTORY: THE PATIENT IS A 67-YEAR-OLD MALE WHO IS STATUS POST INDEX RIGHT TOTAL HIP REPLACEMENT ON (B)(6) 2017 USING EXACTECH COMPONENTS, SPECIFICALLY NOVATION CROWN CUP GXL ACETABULAR LINER, GROUP 2, SIZE 36 MM INNER DIAMETER, AS WELL AS A 52 MM OUTER DIAMETER CROWN CUP AND AN ALTEON TAPERED WEDGE STEM, SIZE 9 EXTENDED OFFSET WITH A BIOLOX DELTA CERAMIC FEMORAL HEAD, SIZE 36 MM/+7 OFFSET. THE PATIENT HAS GONE ON TO DEVELOP POLYETHYLENE WEAR AND THE RECALL OF THE ACETABULAR POLYETHYLENE LINER HAD BEEN ISSUED. GIVEN THE VISIBLE WEAR ON X-RAY AND OSTEOLYSIS AROUND THE PORTION OF THE ACETABULAR COMPONENT, THE PLAN WAS FOR REVISION OF THE ACETABULAR POLYETHYLENE. CLEAR SYNOVIAL JOINT FLUID WAS ASPIRATED, AS WELL AS PART OF THE CAPSULAR TISSUE AND THESE WERE SENT FOR CULTURE. THERE WAS NO EVIDENCE OF ANY GROSS INFECTION. THE ACETABULAR LINER WAS THEN REMOVED USING THE SCREW TECHNIQUE. THERE WAS FOUND TO BE VISIBLE POLYETHYLENE WEAR WITHIN THE WEIGHTBEARING PORTION OF THE POLYETHYLENE LINER. A DRESSING WAS PLACED. AN ABDUCTION PILLOW WAS PLACED. THE PATIENT WAS AWAKENED AND TRANSFERRED TO RECOVERY IN STABLE CONDITION. THERE WERE NO COMPLICATIONS. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AND OSTEOLYSIS. AS A RESULT, THE PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 5 YEARS AND 2 MONTHS AFTER INITIAL IMPLANTATION. DURING THE REVISION SURGERY WEAR OF THE ACETABULAR LINER WAS NOTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 227567 | NV GXL LINER LIPPED 36MM ID GROUP 2 | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED | JDI | EXACTECH, INC. | 01-030-42-0536 | UNK | 10885862207036 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male | Required Intervention | SEE H10 |