G7 ACETABULAR SCREW
Report
- Report Number
- 0001825034-2025-03882
- Event Type
- Injury
- Date Received
- December 8, 2025
- Date of Event
- September 21, 2019
- Report Date
- April 22, 2026
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- PBI
- UDI-DI
- 00880304527461
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D4; G3; H2. THE FOLLOWING SECTIONS WERE CORRECTED: D1; D2. 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: D4; G3; H2; H3; H4; H6; H10. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: 3-YEAR POST-OP, PATIENT REPORTS SOMETIMES PARTICIPATING IN ACTIVITIES SUCH AS WALKING. MODERATE PAIN, SLIGHT LIMP, CANE USED MOST OF THE TIME. OFFICE VISIT, PAIN 1 OUT OF 10, NO FURTHER PROBLEMS REPORTED. AMBULATES WITH WALKER. 5-YEAR POST-OP, PATIENT REPORTS BEING MOSTLY INACTIVE. MODERATE PAIN, SLIGHT LIMP, USES TWO CANES. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.
(B)(4). D10: CAT# 650-1058 LOT# 771480 CER BIOLOXD OPTION HD 40MM, CAT# 650-1064 LOT# 843540 CER OPTION TYPE 1 TPR SLEVE -6. 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 3500A WILL BE SUBMITTED.
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT APPROXIMATELY THREE YEARS POST-HIP SURGERY, THE PATIENT EXPERIENCED MODERATE PAIN AND USING CANES FOR AMBULATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2438805 | G7 ACETABULAR SCREW | PROSTHESIS, HIP | PBI | ZIMMER BIOMET, INC. | 3709227 | 00880304527461 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |