OXFORD PH3 CEMENTLESS FEM SZ M
Report
- Report Number
- 3002806535-2025-00241
- Event Type
- Malfunction
- Date Received
- June 20, 2025
- Date of Event
- June 10, 2025
- Report Date
- November 4, 2025
- Manufacturer
- BIOMET UK LTD.
- Product Code
- NRA
- UDI-DI
- 00887868353772
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). D-4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). G2 ¿ FOREIGN ¿ GERMANY. G-4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS P010014. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; G3; G6; H2; H3; H6; H11 THE FOLLOWING SECTION WAS CORRECTED: H6 - INVESTIGATION CONCLUSIONS COMPLAINT CAN BE CONFIRMED THROUGH THE RETURNED PRODUCT ANALYSIS. A HAIR-LIKE FOREIGN MATERIAL WAS CONFIRMED TO BE EMBEDDED WITHIN THE ADHESIVE LAYER OF THE TYVEK SEAL. UPON RECEIPT OF THE PRODUCT AT THE ZIMMER BIOMET COMPLAINTS LABORATORY, AND AS EVIDENCED IN THE PHOTOGRAPHS PROVIDED BY THE REPORTING HOSPITAL, THE TYVEK LID HAD ALREADY BEEN PEELED BACK. GIVEN THE NATURE AND LOCATION OF THE CONTAMINATION¿SPECIFICALLY, ITS ENTRAPMENT WITHIN THE GLUE LAYER¿IT IS HIGHLY PROBABLE THAT THE FOREIGN MATERIAL WAS INTRODUCED DURING THE STERILE PACKAGING PROCESS. THE MOST LIKELY POINT OF INTRODUCTION IS DURING THE TYVEK LIDDING OPERATION AT THE MANUFACTURING SITE. ROOT CAUSE HAS BEEN IDENTIFIED AS THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO MANUFACTURING. 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G3, G6, H2, H3, H6, H11. THE FOLLOWING SECTIONS WERE CORRECTED: H6 - COMPONENT CODE. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THAT THE CAVITY WAS FOUND TO HAVE A HAIR LIKE MATERIAL CAUGHT WITHIN THE ADHESIVE RESIDUE ATTACHED TO THE CAVITY. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED 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.
IT WAS REPORTED THAT WHEN UNPACKING THE IMPLANT, IT WAS DISCOVERED THAT A HAIR WAS WELDED INTO THE UPPER EDGE OF THE PACKAGING. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 748046 | OXFORD PH3 CEMENTLESS FEM SZ M | KNEE PROSTHESIS | NRA | BIOMET UK LTD. | 7828780 | 00887868353772 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |