G7 LONGEVITY HIGH WALL 32MM E
Report
- Report Number
- 0001822565-2023-01702
- Event Type
- Injury
- Date Received
- June 27, 2023
- Date of Event
- October 31, 2022
- Report Date
- May 21, 2025
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- LPH
- UDI-DI
- 00889024519275
- PMA / PMN Number
- K190660
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: AN INITIAL RIGHT THA WAS PERFORMED ON (B)(6) 2022. 3 WEEKS POST OP, THE PATIENT WAS PRESCRIBED OTC TOPICAL MEDICATION FOR PAIN WHICH IS A NORMAL FINDING. SUBSEQUENTLY ON (B)(6) 2022, THE HIP DISLOCATED WHILE IN THE SHOWER AND AN ABDUCTION BRACE WAS ORDERED FOR 6 WEEKS. THE PATIENT DISLOCATED AGAIN ON (B)(6) 2023 AND ANOTHER BRACE WAS ORDERED. NO REVISION HAS OCCURRED TO DATE. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: RIGHT TOTAL HIP ARTHROPLASTY WITH DEVELOPING RADIOLUCENCY ALONG THE ACETABULAR CUP WHICH COULD INDICATE LOOSENING. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT WAS REPORTED THE PATIENT DISLOCATED DUE TO BENDING, HOWEVER THAT OCCURRED MORE THAN 6 WEEKS POST OP. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4). D10: CAT #: 00877503202 / BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 32/0, TAPER 12/14 / 3102189. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. UPDATED: G3, G6, H2, H3, H6. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. ADDITIONAL MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE PATIENT EXPERIENCED REPEAT DISLOCATIONS, HOWEVER LYSIS, LOOSENING OR WEAR WAS NOT NOTED. A REVISION HAS NOT BEEN PERFORMED AT THIS TIME. ROOT CAUSE UNCHANGED. THIS COMPLAINT WAS CONFIRMED BASED ON THE PROVIDED MEDICAL RECORDS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED A PATIENT WAS PRESCRIBED A HIP ABDUCTION BRACE APPROXIMATELY TWO MONTHS¿ POST IMPLANTATION DUE TO A DISLOCATION, TO BE WORN FOR SIX WEEKS. SUBSEQUENTLY, THE PATIENT UNDERWENT AN INTERNAL REDUCTION APPROXIMATELY EIGHT MONTHS¿ POST IMPLANTATION DUE TO A RECURRING DISLOCATION. THE PATIENT WAS ALSO PRESCRIBED AN ABDUCTION BRACE AFTER THE PROCEDURE. TO DATE, NO REVISION HAS BEEN SCHEDULED AND ALL IMPLANTS REMAIN IN PLACE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1452322 | G7 LONGEVITY HIGH WALL 32MM E | PROSTHESIS, HIP | LPH | ZIMMER BIOMET, INC. | NI | 64615803 | 00889024519275 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Female | Required Intervention| H | SEE H10. |