FDA Adverse Event Injury Summary report: N

VANGUARD TIBIAL BEARING CR LIPPED

MDR report key: 7140342 · Received December 21, 2017

Report

Report Number: 0001825034-2017-11433
Event Type: Injury
Date Received: December 21, 2017
Report Date: December 21, 2017
Manufacturer: ZIMMER BIOMET, INC.
Product Code: JWH
PMA / PMN Number: PK171054
Removal / Correction Number: N/A
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). CONCOMITANT MEDICAL PRODUCT: CATALOG #: 141356, REGENEREX PRIMARY PATELLA 3 PEG, LOT # 713640. CATALOG #: 141273, REGENEREX BIOMET PRIMARY TIBIAL TRAY WITH LOCKING BAR, LOT # 104860. CATALOG #: 183066, VANGUARD CR FEMORAL, LOT # 495800. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-07027, 11424.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN, LOOSENING, AND INSTABILITY APPROXIMATELY THREE YEARS POST-IMPLANT OF TOTAL KNEE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
918103	VANGUARD TIBIAL BEARING CR LIPPED	PROSTHESIS, KNEE	JWH	ZIMMER BIOMET, INC.	N/A	074220

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other