COMPRESS XS SHT SPDL W PINS 800LBF
Report
- Report Number
- 0001825034-2024-01007
- Event Type
- Injury
- Date Received
- April 12, 2024
- Date of Event
- March 18, 2024
- Report Date
- September 30, 2024
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- KRO
- UDI-DI
- 00880304509115
- PMA / PMN Number
- K183553
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: DISTAL FEMORAL RESECTION WITH WHAT APPEARS TO BE A HINGED PROSTHESIS RIGHT TOTAL KNEE ARTHROPLASTY. POSSIBLE HARDWARE FAILURE AT THE JUNCTION OF THE PROXIMAL HARDWARE IN THE FEMORAL STEM WHICH DEMONSTRATES SLIGHT ANGULATION. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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.
(B)(4). D10 MEDICAL DEVICES: COMPRESS/OSS 5CM TPR ADAPT W/OSS SC CATALOG#: 178711 LOT#: 65766806 COMPRESS CENTERING SLEEVE 14MM CATALOG#: 178536 LOT#: 396780 COMPRESS SHORT ANCHOR PLUG 12MM CATALOG#: 178554 LOT#: 201390 COMPRESS TRANSVERSE PIN 6PK 32MM CATALOG#: 178527 LOT#: 501730 COMPRESS SHORT ANCHOR PLUG 12MM CATALOG#: 178554 LOT#: 65889607 COMPRESS TRANSVERSE PIN 6PK 36MM CATALOG#: 178528 LOT#: 562900 COMPRESS NUT CO-CR-MO ALLOY CATALOG#: 178512 LOT#: 65753467 OSS RS AXLE CATALOG#: 161035 LOT#: 65816757 OSS POLY TIBIAL BUSHING CATALOG#: 150476 LOT#: 299680 OSS REINFORCED YOKE CATALOG#: 150493 LOT#: 65985059 OSS POLY LOCK PIN CATALOG#: 150478 LOT#: 65734013 OSS RS POLY FEM BUSHINGS SET/2 CATALOG#: 161034 LOT#: 65795550 OSS RS 12MM LS TIBIAL BEARING CATALOG#: 161094 LOT#: 66043842 OSS POR STRAIGHT STEM 10.5X150 CATALOG#: 150448 LOT#: 905350 OSS MOD TIB BASEPLATE 67MM CATALOG#: 150421 LOT#: 65922750 OSS SEGMENTAL STACKING ADAPTER CATALOG#: 150483 LOT#: 65904622 OSS 5CM DIAPHYSEAL SEGMENT CATALOG#: 150465 LOT#: 705810 OSS RS 7 CM MOD SEG FMRL-RT CATALOG#: 161011 LOT#: 612060 TIBIAL PERIMETER CONE RIGHT SIZE LARGE CATALOG#: 42545001523 LOT#: 64627887 TIBIAL CENTRAL CONE SIZE LARGE CATALOG#: 42545000513 LOT#: 65076064 CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS NOT RETURNED BY THE HOSPITAL. 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. UPDATED: B4, B5, G3, G6, H2, H6, AND H11.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY SEVEN MONTHS POST-IMPLANTATION DUE TO AN UNKNOWN FAILURE OF THE COMPRESS PROSTHESIS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY SEVEN MONTHS POST-IMPLANTATION DUE TO AN UNKNOWN FAILURE OF THE COMPRESS PROSTHESIS POSSIBLY DUE TO A SPINDLE OF INAPPROPRIATE DIAMETER. THE SURGEON WANTED TO USE A DIFFERENT DIAMETER SPINDLE AT THE TIME OF INITIAL IMPLANTATION, BUT NONE WERE AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 778805 | COMPRESS XS SHT SPDL W PINS 800LBF | PROSTHESIS, KNEE | KRO | ZIMMER BIOMET, INC. | N/A | 625580 | 00880304509115 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H | SEE H11. |