OSS POLY TIBIAL BUSHING
Report
- Report Number
- 0001825034-2022-01865
- Event Type
- Injury
- Date Received
- August 19, 2022
- Report Date
- November 29, 2022
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- JDI
- PMA / PMN Number
- K002757
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2022-01862, 0001825034-2022-01863, 0001825034-2022-01864, 0001825034-2022-01866, 0001825034-2022-01867. CONCOMITANT MEDICAL PRODUCTS: OSS RS AXLE ITEM# 161035 LOT# 821880, OSS POLY LOCK PIN ITEM# 150478 LOT# 289470, OSS RS POLY FEM BUSHINGS SET/2 ITEM# 161034 LOT# 838700, OSS TIBIAL POLY BEARING 20MM ITEM# 150414 LOT# 351350, OSS REINFORCED YOKE ITEM# 150493 LOT# 529730, OSS TIB BLOCK 20X63/67 ML/LR ITEM# 150430 LOT# 246240, OSS TIB BLK AUG 10X63/67 UNIV ITEM# 150426 LOT# 626690, CPS ANCHOR PLUG 14MM ITEM# 178404 LOT# 136710, CPS TRANSVERSE PIN 6PK 36MM ITEM# 178528 LOT# 889380, CPS SM M-H F SPINDLE 12MM PCHA ITEM# 178472 LOT# 240530, CPS NUT CO-CR-MO ALLOY ITEM# 178512 LOT# 485340, CPS/OSS 5CM TPR ADAPT W/OSS SC ITEM# 178711 LOT# 821510, OSS RS 7 CM MOD SEG FMRL-LT ITEM# 161012 LOT# 547240, CPS CENTERING SLEEVE 16MM ITEM# 178538 LOT# 818860, COBALT MV BONE CEMENT 40GM B ITEM# 402439 LOT# 187910. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THIS ITEM WAS REPORTED IN ERROR. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED. ADDITIONAL INFORMATION RECEIVED INDICATES THAT ONLY THE CUSTOM TIBIAL BUSHINGS WERE WORN.
THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
IT WAS REPORTED THAT A PATIENT IS BEING CONSIDERED FOR A REVISION TO REPLACE POLY COMPONENTS DUE TO UNKNOWN REASONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.
UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THIS ITEM WAS REPORTED IN ERROR. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED. ADDITIONAL INFORMATION RECEIVED INDICATES THAT ONLY THE CUSTOM TIBIAL BUSHINGS WERE WORN.
IT WAS REPORTED THAT PATIENT WAS COMPLAINING OF LACK OF KNEE STABILITY. SURGEON SHARED HIS INPUT THAT HE BELIEVED THE TIBIA BUSHING COMPONENTS HAD BEGUN TO FAIL BASED ON X-RAYS OF THE KNEE JOINT AND LOCATION OF AXLE RELATIVE TO THE TIBIA BODY THROUGH HOLE THAT HOUSED THE BUSHINGS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2847153 | OSS POLY TIBIAL BUSHING | PROSTHESIS, HIP | JDI | ZIMMER BIOMET, INC. | N/A | 183060 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other | SEE H10 |