PSN MC VE ASF R 11MM 8-11/GH
Report
- Report Number
- 3007963827-2025-00483
- Event Type
- Injury
- Date Received
- December 2, 2025
- Date of Event
- November 10, 2025
- Report Date
- December 23, 2025
- Manufacturer
- ZIMMER ORTHOPAEDIC MFG. LTD.
- Product Code
- MBH
- UDI-DI
- 00889024468504
- PMA / PMN Number
- K150090
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). G2- AUSTRALIA. H3- CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
UPON REASSESSMENT OF THE INFORMATION, IT WAS DETERMINED THAT THIS ITEM WAS REPORTED IN ERROR. THERE ARE NO ALLEGATIONS AGAINST THE ARTICULAR SURFACE AS THE REPORTED ISSUE IS RELATED TO A SUSPECTED INFECTION THAT OCCURRED MORE THAN SEVEN MONTHS POST IMPLANTATION. PLEASE VOID PREVIOUS REPORT REGARDING THE ARTICULAR SURFACE.
IT WAS REPORTED THAT A PATIENT¿S ARTICULAR SURFACE WAS REVISED APPROXIMATELY SEVEN MONTHS POST IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.
UPON REASSESSMENT OF THE INFORMATION, IT WAS DETERMINED THAT THIS ITEM WAS REPORTED IN ERROR. THERE ARE NO ALLEGATIONS AGAINST THE ARTICULAR SURFACE AS THE REPORTED ISSUE IS RELATED TO A SUSPECTED INFECTION THAT OCCURRED MORE THAN SEVEN MONTHS POST IMPLANTATION. PLEASE VOID PREVIOUS REPORT REGARDING THE ARTICULAR SURFACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1900774 | PSN MC VE ASF R 11MM 8-11/GH | PROSTHESIS, KNEE | MBH | ZIMMER ORTHOPAEDIC MFG. LTD. | 66704070 | 00889024468504 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H |