QD KNEE BUSHING SET
Report
- Report Number
- 0001825034-2022-02689
- Event Type
- Injury
- Date Received
- November 29, 2022
- Date of Event
- February 23, 2023
- Report Date
- August 9, 2023
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- JWH
- PMA / PMN Number
- CUSTOM
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). CONCOMITANT MEDICAL PRODUCTS-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 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. SHOW LESS.
THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, AND H10 NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES: MILD-TO-MODERATE VALGUS ALIGNMENT OF THE KNEE WITH ANGULATION GREATEST AT THE BUSHING, FURTHER EVALUATION IS LIMITED WITHOUT PRIOR COMPARATIVE IMAGES. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CORRECTED: H6 COMPONENT CODES. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES: PRESENCE OF MILD-TO-MODERATE VALGUS ALIGNMENT OF THE KNEE WITH ANGULATION GREATEST AT THE TIBIAL BUSHING. THE HARDWARE OTHERWISE APPEARS UNREMARKABLE WITHOUT FRACTURE OR AREAS OF PERIPROSTHETIC LUCENCIES. LIMITED EVALUATION OF THE BONES WITHOUT OBVIOUS ACUTE ABNORMALITY. BUSHING FAILURE IS SUGGESTED BASED UPON VALGUS ALIGNMENT OF THE KNEE AND ABNORMAL ALIGNMENT BETWEEN THE AXLE AND TIBIA/HARDWARE COMPONENT THAT HOUSED THE BUSHINGS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS / ANOMALIES IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS RECEIVED WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D6B- (B)(6) 2023.
THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10- ADDITIONAL ASSOCIATED MEDICAL PRODUCT OSS 17X170 POR STM SIDPLATE HA ITEM# CP115563 LOT# UNKNOWN. OSS 155MM INTERC SIDE EXP ITEM# CP115564 LOT# UNKNOWN. QD 5CM LEFT FEMORAL W/LOCKPINS ITEM# CP115565 LOT# UNKNOWN. QD 1.5CM MOD TIBIAL 51MM TRAY ITEM# CP115566 LOT# UNKNOWN. QD KNEE AXLE ITEM# CP115134 LOT# UNKNOWN. QD LT BEARING SET ITEM# CP115511 LOT# UNKNOWN.
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.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO INSTABILITY AND IMPLANT WEAR. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE 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 |
|---|---|---|---|---|---|---|---|
| 2527505 | QD KNEE BUSHING SET | PROSTHESIS, KNEE | JWH | ZIMMER BIOMET, INC. | N/A | 625650 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Male | Hospitalization| R| O | SEE H10| SEE H10 FOR ADDITIONAL ASSOCIATED MEDICAL PRODUCT |