ZPS SMALL FRAG ONE-THIRD TUBULAR PLT 8 HOLE
Report
- Report Number
- 0001822565-2025-03804
- Event Type
- Injury
- Date Received
- October 21, 2025
- Report Date
- May 21, 2026
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- HRS
- UDI-DI
- 00889024358676
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). D10: MEDICAL PRODUCTS: ITEM#: UNKNOWN, UNKNOWN SCREW; LOT#: UNKNOWN. G2: FOREIGN: UNITED KINGDOM. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, G3, G6, H2, H4 H11. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D10: G3, G6, H2, H6, H11. D10: 3.5MM CORTICAL SCREW SELF TAPPING 36MM LOT 63373615, REF 47-4835-036-01. 3.5MM CORTICAL SCREW SELF TAPPING 28MM LOT 64628363, REF 47-4835-028-01. 3.5MM CORTICAL SCREW SELF TAPPING 22MM LOT 64487013, REF 47-4835-022-01. 3.5MM CORTICAL SCREW SELF TAPPING 16MM LOT 65031719, REF 47-4835-016-01 3.5MM CORTICAL SCREW SELF TAPPING 14MM LOT 64913101, REF 47-4835-014-01. 3.5MM CORTICAL SCREW SELF TAPPING 12MM LOT 64775561, REF 47-4835-012-01. 3.5MM CORTICAL SCREW SELF TAPPING 30MM LOT 63357954, REF 47-4835-030-01. 4.0MM CANCELLOUS SCREW FULLY THREADED 16MM LOT 64372273, REF 47-4840-016-00. 4.0MM CANCELLOUS SCREW FULLY THREADED 10MM LOT 63282069, REF 47-4840-010-00. 4.0MM CANCELLOUS SCREW FULLY THREADED 12MM LOT 6330357, REF 47-4840-012-00. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SURGERY APPROXIMATELY THREE (YEARS) AGO. SUBSEQUENTLY, THE PATIENT REPORTS PROMINENT/PAINFUL AROUND IMPLANT WHEN RUNNING LONG DISTANCE. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION RECEIVED AT THIS TIME.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 146902 | ZPS SMALL FRAG ONE-THIRD TUBULAR PLT 8 HOLE | IMPLANT/TRAUMA | HRS | ZIMMER BIOMET, INC. | 64373481 | 00889024358676 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |