FDA Adverse Event Injury Summary report: N

UNKNOWN KNEE

MDR report key: 6964400 · Received October 20, 2017

Report

Report Number: 0001825034-2017-09249
Event Type: Injury
Date Received: October 20, 2017
Report Date: October 19, 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

Narratives

Additional Manufacturer Narrative · 1

ZIMMER BIOMET COMPLAINT- (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER AND LOT NUMBER OF THE DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD 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. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. O¿DONNELL, T., & NEIL, M. J. (2010). THE REPICCI II UNICONDYLAR KNEE ARTHROPLASTY 9-YEAR SURVIVORSHIP AND FUNCTION. CLINICAL ORTHOPAEDICS AND RELATED RESEARCH, 468(NO. 11), 3094-3102. 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 BETWEEN JULY 1999 AND SEPTEMBER 2000 ON AN UNKNOWN SIDE. SUBSEQUENTLY, PATIENT WAS REVISED DUE TO PROGRESSION OF DISEASE TO LATERAL AND PATELLOFEMORAL COMPARTMENTS ON AN UNKNOWN DATE 9.1 YEARS AFTER INITIAL IMPLANTATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
744543	UNKNOWN KNEE	KNEE PROSTHESIS	JWH	ZIMMER BIOMET, INC.	NI	NI

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R