CMK MOD 12/14 SZ202 L130
Report
- Report Number
- 3006946279-2025-00124
- Event Type
- Injury
- Date Received
- November 24, 2025
- Date of Event
- October 24, 2025
- Report Date
- January 8, 2026
- Manufacturer
- BIOMET FRANCE S.A.R.L.
- Product Code
- LZO
- UDI-DI
- 03599870015322
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). D4 - THIS PRODUCT IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). G2 - FOREIGN: JAPAN. G4 - THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K192236. 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.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H11. UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT AND MEDWATCH REPORT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 3002806535.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED CARDIOPULMONARY ARREST INTRA-OPERATIVELY. THE SURGERY WAS COMPLETED IMMEDIATELY THEREAFTER; HOWEVER, THE PATIENT¿S CURRENT CONDITION IS UNKNOWN. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 237531 | CMK MOD 12/14 SZ202 L130 | HIP PROSTHESIS | LZO | BIOMET FRANCE S.A.R.L. | 0001866625 | 03599870015322 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| H |