FDA Adverse Event Injury Summary report: N

UNKNOWN KNEE

MDR report key: 7000677 · Received November 3, 2017

Report

Report Number: 0001825034-2017-09929
Event Type: Injury
Date Received: November 3, 2017
Report Date: November 3, 2017
Manufacturer: ZIMMER BIOMET, INC.
Product Code: JWH
PMA / PMN Number: PN/A
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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. O'DONNELL, T. "THE REPICCI II UNICONDYLAR KNEE ARTHOPLASTY" (2010). CLINICAL ORTHOPAEDIC RELATED RESEARCH. DOI 10.1007/S11999-010-1474-6.

Description of Event or Problem · 1

IT WAS REPORTED IN THE JOURNAL ARTICLE, "THE REPICCI II UNICONDYLAR KNEE ARTHROPLASTY 9-YEAR SURVIVORSHIP AND FUNCTION" THAT THE PATIENT UNDERWENT A KNEE PROCEDURE ON AN UNKNOWN DATE ON AN UNKNOWN SIDE. SUBSEQUENTLY, PATIENT WAS REVISED DUE TO PROGRESSION OF DISEASE TO LATERAL AND PATELLOFEMORAL COMPARTMENTS ON AN UNKNOWN DATE 7.3 YEARS AFTER INITIAL IMPLANTATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
777965	UNKNOWN KNEE	PROSTHESIS, KNEE	JWH	ZIMMER BIOMET, INC.	N/A	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1