MOD ARTHRO NL 1CM ELIP CNCTR
Report
- Report Number
- 0001825034-2022-01801
- Event Type
- Injury
- Date Received
- August 8, 2022
- Date of Event
- July 19, 2022
- Report Date
- December 7, 2022
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- HSB
- UDI-DI
- 00880304083035
- PMA / PMN Number
- K042409
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. D10 - MEDICAL PRODUCT: MOD ARTHRO NL 1CM ELIP CNCTR CATALOG # CP260606 LOT # 075550; OSS CEMENTED IM STEM 14X150 CATALOG # 150368 LOT # 549900; MOD ARTHRO XL HD SM THD LK SCR CATALOG # CP260610 LOT # 410170; MOD ARTHRO XL HD SM THD LK SCR CATALOG # CP260610 LOT # 082520; OSS CMNTD PROX TIB STEM 13X150 CATALOG # 150446 LOT # 092830; D ARTHRO NL LOCK COLLAR SCR CATALOG # CP260604 LOT # 051420; MOD ARTHRO 5 DEG LCK COLLAR CATALOG # CP260601 LOT # 803080. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE PRODUCT LOCATION IS UNKNOWN. 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. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. NO MEDICAL RECORDS WERE PROVIDED. X-RAY REVIEW BY MMI CONFIRM FRACTURE OF THE TIBIAL CONNECTOR OF THE RIGHT KNEE OSS SYSTEM ARTHROPLASTY WITH RESULTING VARUS ALIGNMENT. BONE QUALITY IS OSTEOPENIC. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE ONE YEAR POST IMPLANTATION DUE TO IMPLANT FRACTURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2532277 | MOD ARTHRO NL 1CM ELIP CNCTR | PROSTHESIS KNEE | HSB | ZIMMER BIOMET, INC. | N/A | 119450 | 00880304083035 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Male | Required Intervention| H | SEE H10 NARRATIVE |