G7 DUAL MOBILITY ACETABULAR SYSTEM
Report
- Report Number
- 0001825034-2025-00544
- Event Type
- Injury
- Date Received
- March 4, 2025
- Date of Event
- January 28, 2025
- Report Date
- July 9, 2025
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- LPH
- UDI-DI
- 00880304703520
- PMA / PMN Number
- K150522
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). D10: (B)(6) ITEM NAME BEARING 28 MM I.D. 44 MM O.D. SIZE F LOT # 66882645; (B)(6) 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
(B)(4) THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D4; G3; E1; H2. THE FOLLOWING SECTIONS WERE CORRECTED: A2; B7; D1; D5; G2. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3; H2; H3; H4; 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 RELATED TO THE REPORTED EVENT. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PATIENT HAD AN INITIAL RIGHT THA AND HAD A REVISION DUE TO A TWISTING INJURY CAUSING PAIN AND SUPERIOR DISLOCATION. STEM WAS STABLE. THE CUP WAS A LITTLE ANTEVERTED BUT NOT BAD, BUT IT WAS DECIDED TO REVISE THE CUP. A POST-REVISION 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.
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 676830 | G7 DUAL MOBILITY ACETABULAR SYSTEM | PROSTHESIS, HIP | LPH | ZIMMER BIOMET, INC. | 66624090 | 00880304703520 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male | Required Intervention| H | PLEASE SEE H11 |