MAXIM BIOMET FIN BROACH TIB PUNCH
Report
- Report Number
- 0001825034-2025-03972
- Event Type
- Injury
- Date Received
- December 15, 2025
- Date of Event
- November 20, 2025
- Report Date
- April 1, 2026
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- HWP
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A2; B4; B5; D2; G1; G3; G6; H1; H2; H3; H6. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. THE EVENT IS CONFIRMED. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THAT A PORTION OF THE PUNCH HAS FRACTURED NEAR WHERE THE PUNCH ASSEMBLES WITH THE HANDLE. AS THE DEVICE WAS NOT RETURNED, FURTHER EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: AP AND LATERAL VIEWS OF THE KNEE SHOW IMMEDIATE POSTOPERATIVE CHANGES OF TOTAL KNEE ARTHROPLASTY. ON BOTH VIEWS THERE IS A LINEAR METALLIC DENSITY IN THE PROXIMAL TIBIAL METAPHYSIS DISTAL TO THE TIP OF THE TIBIAL KEEL. A DEFINITIVE ROOT CAUSE CANNOT 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D1; D2; D4; G1; G3; G4; G6; H1; H2. 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: A2; A4; B4; B5; B7; D2; G1; G3; G6; H1; H2 THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
(B)(4). G2: FOREIGN COUNTRY: MEXICO. CUSTOMER HAS INDICATED THAT THE REMAINDER OF THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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; D2; G1; G3; G6; H1; H2. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT THE TEST FIN BROKE UPON IMPACT WHILE PLACING THE TIBIAL COMPONENT. THE BROKEN PIECE OF THE DEVICE FELL INTO THE HOLE OF THE PROSTHESIS INTO THE TIBIAL MEDULLARY CANAL. THE RETAINED PIECE WAS NOT DISCOVERED UNTIL POST-OP X-RAYS WERE TAKEN. NO INTERVENTION HAS BEEN TAKEN AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
IT WAS FURTHER REPORTED THAT THE PATIENT HAS NOT HAD ANY POST-OP COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 765280 | MAXIM BIOMET FIN BROACH TIB PUNCH | INSTRUMENT, KNEE | HWP | ZIMMER BIOMET, INC. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |