FDA Adverse Event Death Summary report: N

UNKNOWN NEXGEN KNEE TIBIA TRAY

MDR report key: 6964806 · Received October 20, 2017

Report

Report Number: 0001822565-2017-07247
Event Type: Death
Date Received: October 20, 2017
Date of Event: February 4, 2017
Report Date: October 20, 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: KS
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). MEDICAL PRODUCT: UNKNOWN NEXGEN KNEE FEMORAL CAT#: UNK, LOT#: UNK. UNKNOWN NEXGEN KNEE BEARING CAT#: UNK, LOT#: UNK. REPORT SOURCE: FOREIGN- (B)(6). LITERATURE: YOUNG-HOO KIM, JANG-WON PARK, JUN-SHIK KIM ¿DO HIGH-FLEXION TOTAL KNEE DESIGNS INCREASE THE RISK OF FEMORAL COMPONENT LOOSENING?¿ THE JOURNAL OF ARTHROPLASTY 32 (2017) 1862-1868. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBERS ARE UNKNOWN. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:0001822565 - 2017 - 07246, 0001822565 - 2017 - 07247, 0001822565 - 2017 - 07248.

Description of Event or Problem · 1

IT WAS REPORTED IN A JOURNAL ARTICLE THAT TEN STUDY PARTICIPANTS DIED FOR UNKNOWN REASONS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
745079	UNKNOWN NEXGEN KNEE TIBIA TRAY	PROSTHESIS, KNEE	JWH	ZIMMER BIOMET, INC.	N/A	NI

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death	SEE H10