OSS REINFORCED YOKE
Report
- Report Number
- 0001825034-2022-01867
- Event Type
- Injury
- Date Received
- August 19, 2022
- Report Date
- November 29, 2022
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- KRO
- PMA / PMN Number
- K052685
- 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, 0001825034-2022-01865, 0001825034-2022-01866. MEDICAL PRODUCT: 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 POLY TIBIAL BUSHING, ITEM# 150476, LOT# 183060. OSS TIBIAL POLY BEARING 20 MM, ITEM# 150414, LOT# 351350. 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 14 MM, ITEM# 178404, LOT# 136710. CPS TRANSVERSE PIN 6 PK 36 MM, ITEM# 178528, LOT# 889380. CPS SM M-H F SPINDLE 12 MM PCHA, ITEM# 178472, LOT# 240530. CPS NUT CO-CR-MO ALLOY, ITEM# 178512, LOT# 485340. CPS/OSS 5 CM TPR ADAPT W/OSS SC, ITEM# 178711, LOT# 821510. OSS RS 7 CM MOD SEG FMRL-LT, ITEM# 161012. LOT# 547240. CPS CENTERING SLEEVE 16 MM, ITEM# 178538. LOT# 818860. COBALT MV BONE CEMENT 40 GM 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 |
|---|---|---|---|---|---|---|---|
| 2848188 | OSS REINFORCED YOKE | PROSTHESIS, KNEE | KRO | ZIMMER BIOMET, INC. | N/A | 529730 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |