NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS
Report
- Report Number
- 1038671-2022-00597
- Event Type
- Injury
- Date Received
- May 21, 2022
- Date of Event
- April 28, 2022
- Report Date
- June 24, 2023
- Manufacturer
- EXACTECH, INC.
- Product Code
- JDI
- UDI-DI
- 10885862024329
- PMA / PMN Number
- K070479
- Removal / Correction Number
- Z-1729-2022
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONCOMITANT MEDICAL PRODUCTS: NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS (CAT# 136-36-52 / SERIAL# (B)(4)); COCR FEM HEAD 36MM +0 OFFSET 12/14 (CAT# 142-36-00 / SERIAL# (B)(4)); COCR FEM HEAD 36MM +3.5 OFFSET 12/14 (CAT# 142-36-03 / SERIAL# (B)(4)); NV CROWN CUP CLSTR HOLE 52MM GROUP 2 (CAT# 180-01-52 / SERIAL# (B)(4)); NV CROWN CUP CLSTR HOLE 52MM GROUP 2 (CAT# 180-01-52 / SERIAL# (B)(4)); WEDGE PLASMA X/O SZ 5 (CAT# 188-01-05 / SERIAL# (B)(4)); WEDGE PLASMA X/O SZ 5 (CAT# 188-01-05 / SERIAL# (B)(4)). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS G3, G6, H2, H3, H6 AND H9 HAVE BEEN UPDATED ACCORDINGLY. (H3) THE EARLY WEAR MONITORING REPORTED WAS LIKELY THE RESULT OF INCREASED BIOMECHANICAL STRESSORS ON THE JOINTS SECONDARY TO PATIENT-RELATED CONDITIONS AND EDGE-DIRECTED LOADING THAT LED TO INCREASED PROSTHESIS WEAR. THE COMBINATION OF RISK FACTORS INCLUDING, USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS MAY HAVE ALSO BEEN A CONTRIBUTING FACTOR TO THE EARLY PROSTHESIS WEAR. THE MOST PROBABLE ROOT CAUSE ASSOCIATED WITH THE REPORTED EVENT OF "PROSTHESIS WEAR¿ IS ASSOCIATED WITH MATERIAL DAMAGE TO A SURFACE, USUALLY INVOLVING PROGRESSIVE LOSS OR DISPLACEMENT OF MATERIAL, DUE TO RELATIVE MOTION BETWEEN THAT SURFACE AND A CONTACTING SUBSTANCE OR SUBSTANCES. SECTION D9: DEVICE AVAILABLE FOR EVALUATION.
AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS D6B, G3, G6, H2 AND H3 HAVE BEEN UPDATED ACCORDINGLY. SECTION D6B: EXPLANTED, GIVE DATE (H3) THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF INCREASED BIOMECHANICAL STRESSORS ON THE JOINTS SECONDARY TO PATIENT-RELATED CONDITIONS AND A COMBINATION OF THE RISK FACTORS INCLUDING, USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS MAY HAVE ALSO BEEN A CONTRIBUTING FACTOR TO THE EARLY PROSTHESIS WEAR. MOREOVER, INCLUDING BUT NOT LIMITED TO SIGNIFICANT EDGE LOADING OF THE FEMORAL HEAD ON THE ACETABULAR LINER, BEING IMPLANTED WITH A LATERALIZED LINER, AND COMBINATION OF LARGEST AVAILABLE FEMORAL HEAD AND/OR THINNEST AVAILABLE ACETABULAR LINER. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. THE MOST PROBABLE ROOT CAUSE ASSOCIATED WITH THE REPORTED EVENT OF "PROSTHESIS WEAR¿ IS ASSOCIATED WITH MATERIAL DAMAGE TO A SURFACE, USUALLY INVOLVING PROGRESSIVE LOSS OR DISPLACEMENT OF MATERIAL, DUE TO RELATIVE MOTION BETWEEN THAT SURFACE AND A CONTACTING SUBSTANCE OR SUBSTANCES.
AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL LEFT THA, THE 40 Y/O MALE PATIENT VISITED SURGEON AND LEFT HIP HAS CLEAR PREMATURE WEAR. THE LEFT HIP HAS ASYMMETRIC POLY WEAR, BUT LUCKILY NO LYSIS. PATIENT WAS TOLD TO COME BACK IN 6 MONTHS. NO OTHER INFORMATION PROVIDED
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1200337 | NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED | JDI | EXACTECH, INC. | NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS | UNK | 10885862024329 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Male | Required Intervention |