FDA Adverse Event Injury Summary report: N

UNKNOWN CUP

MDR report key: 20852334 · Received December 5, 2024

Report

Report Number: 0001825034-2024-02867
Event Type: Injury
Date Received: December 5, 2024
Date of Event: November 4, 2024
Report Date: August 1, 2025
Manufacturer: ZIMMER BIOMET, INC.
Product Code: KWZ
UDI-DI: 00880304203600
PMA / PMN Number: K030047
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

(B)(4). D10: CAT #: 11-107016 / FREEDOM CONSTR HD 36MM T1 -6MM / LOT #: 140310. G2: AUSTRALIA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Additional Manufacturer Narrative · 0

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. UPDATED: A4, B3, B5, B7, D6B, G3, G6, H2.

Additional Manufacturer Narrative · 0

(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: UPDATED: B3; D1; D4; D6A; D6B; B4; B5; G3; G4; H6. B3 AND D6B ARE BEING UPDATED TO UNKNOWN. AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Additional Manufacturer Narrative · 0

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4;D10;G3;H2;H3;H6;H10. D10: ITEM# UNKNOWN LOT# UNKNOWN / UNKNOWN HEAD. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. REPORTED EVENT IS NOT RELATED TO A COMBINATION OF PRODUCTS. HOWEVER, THE LINER AND HEAD WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. THROUGH FOLLOW-UP IT WAS IDENTIFIED, THE SHELL AND STEM USED WERE COMPETITOR IMPLANTS. A RADIOGRAPH WAS PROVIDED; HOWEVER, NOT REVIEWED AS THERE ARE NO ALLEGATIONS AGAINST THE ZIMMER BIOMET IMPLANTS, AND A REVIEW WOULD NOT ENHANCE INVESTIGATION. THE ROOT CAUSE OF THE REPORTED EVENT WAS ATTRIBUTED TO OFF-LABEL USE AS THE ZIMMER BIOMET DEVICES WERE USED AS SPACERS AS PART OF A 2-STAGE REVISION. ZIMMER BIOMET HAS NOT CONFIRMED THE DEVICES ARE SUITABLE FOR USE AS SPACERS AND IS THEREFORE CONSIDERED OFF-LABEL USE. AS PER INSTRUCTIONS FOR USE (IFU) IT STATES UNDER CONTRADICTIONS DO NOT USE IF "ANY ACTIVE OR SUSPECTED INFECTION IN OR ABOUT THE HIP". DURING FOLLOW-UP IT WAS NOTED THE SURGEON IS AWARE THIS IS OFF-LABEL USE. THE LINER AND HEAD WERE USED WITH A COMPETITOR SHELL AND STEM. THIS IS CONSIDERED OFF LABEL USE PER IFU. IT STATES UNDER WARNINGS "THE BIOMET FREEDOM CONSTRAINED LINER SYSTEM IS TO BE USED ONLY WITH BIOMET FEMORAL, ACETABULAR SHELL, AND FEMORAL FREEDOM HEAD COMPONENTS" IT IS UNKNOWN IF THIS OFF LABEL USE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. UNABLE TO CONFIRM COMPLAINT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Additional Manufacturer Narrative · 0

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. UPDATED: G3, G6, H2, H3, H6. AN UNDATED RADIOGRAPH WAS PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: A LEFT HIP ARTHROPLASTY IS ANATOMICALLY ALIGNED. A CONSTRAINING RING IS INCOMPLETELY VISUALIZED. THERE HAS BEEN RESECTION OF THE PROXIMAL FEMUR. THE TIP OF THE FEMORAL IMPLANT IS NOT INCLUDED. THERE IS NO FRACTURE OR EVIDENCE OF IMPLANT LOOSENING. THERE ARE NO RADIOGRAPHIC SIGNS OF INFECTION, BUT THE IMAGE WAS LIKELY OBTAINED AFTER ARTHROPLASTY REVISION. THE ROOT CAUSE OF THE REPORTED EVENT IS ATTRIBUTED TO OFF-LABEL USE AS THE ZB DEVICES WERE USED AS SPACERS AS PART OF A 2 STAGE REVISION. ZIMMER BIOMET HAS NOT CONFIRMED THE DEVICES ARE SUITABLE FOR USE AS SPACERS AND IS THEREFORE CONSIDERED OFF-LABEL USE. AS PER IFU 01-50-0962 IT STATES UNDER CONTRADICTIONS DO NOT USE IF "ANY ACTIVE OR SUSPECTED INFECTION IN OR ABOUT THE HIP". DURING FOLLOW-UP IT WAS NOTED THE SURGEON IS AWARE THIS IS OFF-LABEL USE. THE LINER AND HEAD WERE USED WITH A COMPETITOR SHELL AND STEM. THIS IS CONSIDERED OFF LABEL USE PER THE IFU. IT STATES ¿THE BIOMET FREEDOM CONSTRAINED LINER SYSTEM IS TO BE USED ONLY WITH BIOMET FEMORAL, ACETABULAR SHELL, AND FEMORAL FREEDOM HEAD COMPONENTS". IT IS UNKNOWN IF THIS OFF LABEL USE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. UNABLE TO CONFIRM COMPLAINT. 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.