FDA Adverse Event Injury Summary report: N

VANGUARD ARCOM POSTERIOR STABILIZED BEARING

MDR report key: 7754238 · Received August 6, 2018

Report

Report Number: 0001825034-2018-04891
Event Type: Injury
Date Received: August 6, 2018
Date of Event: November 5, 2014
Report Date: August 6, 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). CONCOMITANT MEDICAL PRODUCT: VAN PS OPEN INTL FEM-RT 80 CATALOG # 183116 LOT # UNKNOWN, BIOMET CC I-BEAM TRAY 91 MM CATALOG # 141228 LOT # UNKNOWN, SERIES A PAT STD 40 3 PEG CATALOG # 184770 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 THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A MANIPULATION ONE MONTH POST IMPLANTATION DUE TO UNKNOWN REASON.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
595102	VANGUARD ARCOM POSTERIOR STABILIZED BEARING	KNEE PROSTHESIS	JWH	ZIMMER BIOMET, INC.	N/A	NI

Patients

Seq	Age	Sex	Outcome	Treatment
1	56 YR		Required Intervention