FDA Adverse Event Injury Summary report: N

VGD CRUC RET TIB BRG 11X79/83

MDR report key: 7756361 · Received August 7, 2018

Report

Report Number: 0001825034-2018-05669
Event Type: Injury
Date Received: August 7, 2018
Date of Event: November 24, 2015
Report Date: August 2, 2018
Manufacturer: ZIMMER BIOMET, INC.
Product Code: JWH
PMA / PMN Number: PK113550
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2018-05663. MEDICAL PRODUCTS VANGUARD CR ILOK FEM-RT 75, ITEM# 183014, LOT# UNKNOWN; BIOMET CC I-BEAM TRAY 79MM, ITEM# 141225, LOT# UNKNOWN; SERIES A PAT THIN 37X8.6 3 PEG, ITEM# 184788, LOT# UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. 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. 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 A PATIENT UNDERWENT INITIAL RIGHT TOTAL KNEE ARTHROPLASTY AND SUBSEQUENTLY THE PATIENT UNDERWENT MANIPULATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
598800	VGD CRUC RET TIB BRG 11X79/83	PROSTHESIS- KNEE	JWH	ZIMMER BIOMET, INC.	N/A	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	59 YR		Required Intervention