MODULAR ARTHRODESIS ELLIPTICAL DIAPHYSEAL CONNECTOR
Report
- Report Number
- 0001825034-2022-00884
- Event Type
- Injury
- Date Received
- April 14, 2022
- Date of Event
- January 10, 2022
- Report Date
- August 18, 2022
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- HSB
- PMA / PMN Number
- K042409
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). CONCOMITANT DEVICES - MODULAR ARTHRODESIS NAIL 0 DEGREE COLLAR ASSEMBLY CATALOG #: CP260600 LOT #: 831610, MODULAR ARTHRODESIS NAIL ELLIPTICAL DIAPHYSEAL CONNECTOR 3CM CATALOG #: CP260608 LOT #: 451850, ORTHOPEDIC SALVAGE SYSTEM INTERLOK CEMENTED STRAIGHT IM TIBIAL STEM WITH SCREW 13MM X 150MM CATALOG #: 150446 LOT #: 081830, MODULAR ARTHRODESIS NAIL ELLIPTICAL DIAPHYSEAL CONNECTOR 1CM CATALOG #: CP260606 LOT #: 868080 THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS A PORTION OF THE DEVICE WAS DISCARDED AND THE OTHER PORTION REMAINS IMPLANTED. 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: B4, B6, G3, G6, H2, H10.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A1, B4, B5, B6, B7, D1, D2, D4, G3, G4, G6, H2, H6, H10.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED THAT THE PATIENT'S LEG WAS AMPUTATED ABOVE THE KNEE APPROXIMATELY FIVE (5) YEARS FOLLOWING KNEE ARTHROPLASTY AFTER THE PATIENT'S PROSTHESIS FRACTURED WHILE GETTING OUT OF BED AND THE PATIENT FELL. THE PATIENT WAS TAKEN VIA AMBULANCE AFTER THE FALL AND TWO (2) DAYS LATER THE SURGEON AMPUTATED THE LEG. A PORTION OF THE ROD WAS LEFT IN THE LEG TO ALLOW THE PATIENT TO HAVE A PROSTHESIS AT A LATER DATE. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT THE PATIENT'S LEG WAS AMPUTATED ABOVE THE KNEE APPROXIMATELY FIVE (5) YEARS FOLLOWING KNEE ARTHROPLASTY AFTER THE PATIENT'S PROSTHESIS FRACTURED WHILE GETTING OUT OF BED AND THE PATIENT FELL. THE PATIENT WAS TAKEN VIA AMBULANCE AFTER THE FALL AND TWO (2) DAYS LATER THE SURGEON AMPUTATED THE LEG. A PORTION OF THE ROD WAS LEFT IN THE LEG TO ALLOW THE PATIENT TO HAVE A PROSTHESIS AT A LATER DATE. OPERATIVE NOTES FROM THE AMPUTATION NOTED METALLOSIS WAS PRESENT IN THE JOINT WITHOUT EVIDENCE OF INFECTION. AMPUTATION WAS COMPLETED AT THE LEVEL END OF THE BROKEN METALLIC ROD. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED AND THE PATIENT WAS IN STABLE CONDITION IN RECOVERY. THE PATIENT WAS DISCHARGED SIX (6) DAYS LATER. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2012751 | MODULAR ARTHRODESIS ELLIPTICAL DIAPHYSEAL CONNECTOR | HSB | HSB | ZIMMER BIOMET, INC. | N/A | 868080 | |
| 2669667 | MODULAR ARTHRODESIS ELLIPTICAL DIAPHYSEAL CONNECTOR | HSB | HSB | ZIMMER BIOMET, INC. | N/A | 868080 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Hospitalization| S| R | SEE H10 NARRATIVE |