FDA Adverse Event Injury Summary report: N

VNGD ANT STBLZD BRG 14X79

MDR report key: 8793083 · Received July 16, 2019

Report

Report Number: 0001825034-2019-02965
Event Type: Injury
Date Received: July 16, 2019
Date of Event: June 28, 2019
Report Date: July 16, 2019
Manufacturer: ZIMMER BIOMET, INC.
Product Code: JWH
PMA / PMN Number: K171054
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). MEDICAL DEVICES: VANGUARD CR ILOK FEM-RT 75, CATALOG#: 183014, LOT#: J3910422; BIOMET CC CRUCIATE TRAY, 79MM CATALOG#: 141235, LOT#: J3925180; BIOMET TIBIAL LOCKING BAR, CATALOG#: 141205, LOT#: 166730; UNKNOWN STRYKER CEMENT, CATALOG#: NI, LOT#: NI. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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.

Description of Event or Problem · 1

IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT KNEE REVISION FOR INFECTION, POLY SWAP AND WASH OUT AROUND ELEVEN (11) MONTHS AGO. SUBSEQUENTLY, WAS EXPERIENCING A BURNING SENSATION AND PAIN IN HIS KNEE AND WAS AGAIN REVISED DUE TO INFECTION AND A POLY SWAP WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
587229	VNGD ANT STBLZD BRG 14X79	PROSTHESIS, KNEE	JWH	ZIMMER BIOMET, INC.	N/A	341080

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R