OFFSET TIB TRAY NEUT ADAPTOR
Report
- Report Number
- 0001825034-2025-00443
- Event Type
- Injury
- Date Received
- February 24, 2025
- Report Date
- July 21, 2025
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- JWH
- UDI-DI
- 00880304232211
- PMA / PMN Number
- K171054
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). D10-MEDICAL PRODUCT VG 360 UNIV PST FM AUG 70X5, ITEM# 185346, LOT# 138350. VNGD TI FEM SSK 70MM LT , ITEM# CP113127, LOT# 795410. BMT SPLINED KNEE STM V2 20X120, ITEM# 148323, LOT# 855010. BIOMET OFFSET TIBIAL TRAY 71MM, ITEM# 141483, LOT# 866560. BMT SPLINED KNEE STM V2 20X80, ITEM# 148310, LOT# 102900. UNKNOWN ARTICULAR SURFACE. H3- 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.
THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: A4, B4, B5, B7, D2, E1, E2, E3, E4, G1, G2, G3, G6, H1, H2, AND H11. CORRECTION: D6A.
THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, B7, D2, G1, G3, G6, H1, H2, H6, AND H11.
THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. . 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. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: ¿ MOTION HAS IMPROVED "SHE FEELS LIKE SHE COULD HAVE PLACED IN HER KNEE AT ALL TIMES. SHE IS ON PT. SHE TRIED COMPRESSION SLEEVES, BUT NOTHING SEEMS TO BE HELPING. SHE TRIED MELOXICAM WHICH DID NOT HELP," NOT CALLING OUT ADDITIONAL SYMPTOMS/OUTCOMES AS ALLEGATION IS UNCLEAR FROM STATEMENT DICTATED ¿ INCISION C/D/I-NO SIGNS OF INFECTION, MILD SWELLING WITHIN NORMAL LIMITS, ROM 0-125DEG ¿ PATELLA TRACKS SMOOTHLY, EXCELLENT OVERALL ALIGNMENT, KNEE IS STABLE ¿ OVERALL PATIENT IS DOING WELL. THE FEELING OF A VICE AROUND HER KNEE IS VERY DIFFICULT TO FIGURE OUT. IT IS HARD TO TELL IF INFLAMMATION OR JUST SCAR TISSUE PRESENT. A CORTISONE SHOT WAS OFFERED, AND CELEBREX HAS BEEN PRESCRIBED. RADIOGRAPH REPORT, THREE VIEWS OF L KNEE. ¿ EXCELLENT OVERALL ALIGNMENT. ¿ NO EVIDENCE OF POST-OPERATIVE COMPLICATIONS. ¿ NO EVIDENCE OF EARLY SUBSIDENCE OR LOOSENING. ¿ NO EVIDENCE OF FRACTURE OR IMPLANT COMPLICATION. ¿ NORMAL APPEARING POST-OP TOTAL KNEE IMAGES. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS / ANOMALIES IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT IS CONFIRMED THROUGH THE MEDICAL RECORDS. IF ANY FURTHER INFORMATION IS RECEIVED WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE. TO MONITOR FOR TRENDS.
IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PAIN AND AMBULATION DIFFICULTIES APPROXIMATELY TWO YEARS AND TWO AND A HALF MONTHS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PAIN AND AMBULATION DIFFICULTIES APPROXIMATELY TWO YEARS AND TWO AND A HALF MONTHS POST IMPLANTATION. AT FOLLOW-UP VISIT A CORTISONE SHOT WAS OFFERED AND CELEBREX HAS BEEN PRESCRIBED. 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 |
|---|---|---|---|---|---|---|---|
| 404058 | OFFSET TIB TRAY NEUT ADAPTOR | PROSTHESIS, KNEE | JWH | ZIMMER BIOMET, INC. | 146410 | 00880304232211 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other | SEE H11 |