FDA Adverse Event Death Summary report: N

UNKNOWN KUDO ELBOW

MDR report key: 6579940 · Received May 19, 2017

Report

Report Number: 3002806535-2017-00425
Event Type: Death
Date Received: May 19, 2017
Report Date: May 19, 2017
Manufacturer: BIOMET UK LTD.
Product Code: JDC
PMA / PMN Number: PN/A
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NL
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(6). THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, WE ARE FILING THIS REPORT AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K013042. HEIJINK, A. ET AL. "IDENTIFYING METALLOSIS AFTER KUDO TOTAL ELBOW ARTHROPLASTY IS CHALLENGING. A CLINICAL AND RADIOLOGICAL STUDY." ELBOW ARTHROPLASTY IN PERSPECTIVE. 7:125-140. REPORTED EVENTS WERE UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE ARTICLE AND NO PRODUCT WAS RETURNED. DHR AND COMPLAINT HISTORY COULD NOT BE REVIEWED DUE TO THE LACK OF INFORMATION RECEIVED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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: 3002806535-2017-00391, 3002806535-2017-00423, 3002806535-2017-00424 AND 3002806535-2017-00425.

Description of Event or Problem · 1

IT WAS REPORTED IN A JOURNAL ARTICLE THAT 11 PATIENTS WITH ELBOW ARTHROPLASTYS IN THE STUDY EXPIRED DUE TO UNKNOWN CAUSES ON UNKNOWN DATES. NO FURTHER INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
359759	UNKNOWN KUDO ELBOW	PROSTHESIS, ELBOW	JDC	BIOMET UK LTD.	N/A	NI

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death