BEARING 28 MM I.D. 44 MM O.D. SIZE F
Report
- Report Number
- 0001822565-2025-00522
- Event Type
- Injury
- Date Received
- March 4, 2025
- Date of Event
- January 28, 2025
- Report Date
- July 1, 2025
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- LPH
- UDI-DI
- 00889024572584
- PMA / PMN Number
- K190656
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). D10: 110024464 ITEM NAME: G7 DUAL MOBILITY LINER 44MM F, LOT # 66624090; 00877502803 ITEM NAME: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, ø 28/+3.5, TAPER 12/14, LOT # 3201313. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; 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 INFORMATION. D10 - ASSOCIATED PRODUCTS: PART #: 110024464 ITEM NAME: G7 DUAL MOBILITY LINER 44MM F LOT #: 66624090. PART #: 00877502803 ITEM NAME: BIOLOX® DELTA, CERAMIC FEMORAL HEAD LOT #: 3201313. PART #: 110010246 ITEM NAME: G7 OSSEOTI 4 HOLE SHELL LOT #: 65273587. PART #: 574202050 ITEM NAME: FEMORAL STEM CEMENTLESS LOT #: 3205956. PART #: 110034355 ITEM NAME: REFOBACIN BC R 1X40 US LOT #: W50EAL1501.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE {UPDATE/CORRECTED}. UPDATED: G3; H2; H3; H6. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PATIENT HAD A INITIAL RIGHT THA. PATIENT HAD A REVISION DUE TO A TWISTING INJURY CAUSING PAIN AND SUPERIOR DISLOCATION. CONTRIBUTING FACTOR WAS THE CUP WAS A LITTLE ANTEVERTED BUT NOT BAD, BUT IT WAS DECIDED TO REVISE THE CUP. AN X-RAY REPORTS GOOD POSITION AND ALIGNMENT WITH NO EVIDENCE OF FAILURE OR LOOSENING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE MEDICAL RECORDS, THE COMPLAINT IS CONFIRMED. 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.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 26 DAYS POST IMPLANTATION DUE TO A TWISTING INJURY CAUSING PAIN AND DISLOCATION. THE STEM WAS RETAINED AND ALL OTHER IMPLANTS WERE REVISED WITHOUT COMPLICATION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY FOLLOWED BY A REVISION 1 MONTH LATER DUE TO UNRESOLVED PAIN AND WEAKNESS. DURING THIS PROCEDURE THE CUP WAS RETAINED BUT WAS NOTED AS ¿A LITTLE UNDER ANTEVERTED.¿ SUBSEQUENTLY, THE PATIENT WAS REVISED A SECOND TIME APPROXIMATELY 1 MONTH LATER FOLLOWING A TWISTING INJURY CAUSING PAIN AND DISLOCATION. THE STEM WAS RETAINED, AND ALL OTHER IMPLANTS WERE REVISED WITHOUT COMPLICATION.
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 777178 | BEARING 28 MM I.D. 44 MM O.D. SIZE F | PROSTHESIS, HIP | LPH | ZIMMER BIOMET, INC. | 66882645 | 00889024572584 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male | Required Intervention| H | PLEASE SEE H11. |