ARTICULAR SURFACE FIXED BEARING CONSTRAINED POSTERIOR STABILIZED
Report
- Report Number
- 3007963827-2022-00084
- Event Type
- Malfunction
- Date Received
- April 6, 2022
- Date of Event
- March 22, 2022
- Report Date
- May 18, 2022
- Manufacturer
- ZIMMER ORTHOPAEDIC MFG. LTD.
- Product Code
- MBH
- UDI-DI
- 00889024244474
- PMA / PMN Number
- K123459
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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. D10: 42542006702 - TIBIA FIXED CEMENTED RIGHT SIZE D STEM EXTENSION USE REQUIRED - 64835319. 42540000035 - ALL POLY PATELLA CEMENTED 35 MM DIAMETER - 65270980. 42555803405 - TIBIAL AUGMENT CEMENTED HALF BLOCK RIGHT MEDIAL SIZE CD 5 MM - 64353978. 42545000510 - TIBIAL CENTRAL CONE SIZE X-SMALL - 65034282. 42555803205 - TIBIAL AUGMENT CEMENTED HALF BLOCK RIGHT LATERAL SIZE CD 5 MM - 64333007. 42560613513 - STEM EXTENSION 6MM OFFSET SPLINED UNCEMENTED 13 MM DIAMETER - 64739769. 42560613514 - STEM EXTENSION 6MM OFFSET SPLINED UNCEMENTED 14 MM DIAMETER - 64876024. 42556606605 - FEMORAL DISTAL AUGMENT CEMENTED SIZE 9, 9+ 5 MM THICKNESS - 64614849. 42556806605 - FEMORAL POSTERIOR AUGMENT CEMENTED SIZE 9, 9+ 5 MM THICKNESS - 65263702. 42504606612 - FEMUR CEMENTED PLUS RIGHT SIZE 9+ - 64287657. THE FOLLOWING SECTIONS WERE UPDATED: A2; B4; B5; D10; G3; G6; H1; H2; H10. THIS ADDITIONAL INFORMATION DOES NOT CHANGE THE PREVIOUS INVESTIGATION. 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. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND SIGNS OF USE (NICKED AND GOUGED) AND THE DOVETAIL FEATURE IS FLARED AND COMPRESSED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. DAMAGE TO THE ARTICULAR SURFACE CAN OCCUR IF THE ARTICULAR SURFACE IS NOT CORRECTLY PLACED AND ORIENTED BEFORE PUSHING IT USING THE INSERTER INSTRUMENT. DETAILED INSTRUCTIONS FOR INSERTING THE ARTICULAR SURFACE ARE PROVIDED IN PERSONA THE PERSONALIZED KNEE SURGICAL TECHNIQUE. THE ROOT CAUSE IS ATTRIBUTED TO USE ERROR. 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 THE POLY WOULD NOT SEAT PER TECHNIQUE. THE SURGEON COULD NOT GET THE POLY TO SEAT SO HE OPENED A NEW ONE OF THE SAME SIZE AND IT WAS IMPLANTED WITH NO ISSUES. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2338581 | ARTICULAR SURFACE FIXED BEARING CONSTRAINED POSTERIOR STABILIZED | PROSTHESIS, KNEE | MBH | ZIMMER ORTHOPAEDIC MFG. LTD. | N/A | 65206363 | 00889024244474 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | SEE H10 NARRATIVE. |