PSN FEM CR CMT CCR
Report
- Report Number
- 3007963827-2023-00330
- Event Type
- Injury
- Date Received
- December 7, 2023
- Date of Event
- November 17, 2023
- Report Date
- March 27, 2024
- Manufacturer
- ZIMMER ORTHOPAEDIC MFG. LTD.
- Product Code
- JWH
- PMA / PMN Number
- K172524
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED. IT IS NOW VERIFIED THAT THIS DEVICE IS RELATED TO THE EVENT.
(B)(4). D10 - MEDICAL PRODUCT: PSN ASF CR 13MM PLY CATALOG # 42-5110-004-13 LOT # 63634750. PSN TIB NP STM 5 DEG SZ D L CATALOG # 42-5320-067-01 LOT # 65440604. PSN ALL POLY PAT PLY 32MM CATALOG # 42-5400-000-32 LOT # 65649259. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 3007963827-2023-00329 H3 OTHER TEXT : PRODUCT LOCATION UNKNOWN.
UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED. IT IS NOW VERIFIED THAT THIS DEVICE IS RELATED TO THE EVENT.
IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE ELEVEN MONTHS POST IMPLANTATION DUE TO RANGE OF MOTION AND FLEXED KNEE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1127631 | PSN FEM CR CMT CCR | PROSTHESIS KNEE | JWH | ZIMMER ORTHOPAEDIC MFG. LTD. | N/A | 65453540 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H | SEE H10 NARRATIVE. |