FDA Adverse Event Injury Summary report: N

ACCLAIM LINKED POLY HUM YOKE

MDR report key: 2992562 · Received March 7, 2013

Report

Report Number: 1818910-2013-13349
Event Type: Injury
Date Received: March 7, 2013
Date of Event: February 25, 2013
Report Date: February 25, 2013
Manufacturer: DEPUY ORTHOPAEDICS, INC. 1818910
Product Code: JDC
PMA / PMN Number: PK992656
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICES AND X-RAYS ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A PREVIOUS INVESTIGATION WAS CONDUCTED FOR A SIMILAR EVENT AND FOUND THE ULNAR BEARING COMPONENT TO HAVE A MINIMAL CHAMFER THAT MAY LEAD TO PREMATURE POLYETHYLENE WEAR AT CERTAIN CONTACT POINTS. THE PREMATURE WEAR CAUSES THE POLYETHYLENE TO FAIL, WHICH MAY LEAD TO THE POTENTIAL FOR THE LOCKING PIN TO DISASSOCIATE FROM THE ELBOW ASSEMBLY. A VOLUNTARY RECALL FOR THE ULNAR BEARING COMPONENTS WAS INITIATED IN NOVEMBER OF 2005. IN ADDITION, A BUSINESS DECISION WAS MADE TO NO LONGER MARKET THE ELBOW. A VOLUNTARY MARKET WITHDRAWAL WAS ALSO INITIATED FOR THE OTHER PRODUCT CODES OF THE ACCLAIM ELBOW ASSEMBLY. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

Additional Manufacturer Narrative · 1

THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

Description of Event or Problem · 1

THE PATIENT WAS REVISED BECAUSE THE PIN ASSEMBLY DISENGAGED AND THE YOKE WAS WORN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
98184	ACCLAIM LINKED POLY HUM YOKE	POLY INSERT	JDC	DEPUY ORTHOPAEDICS, INC. 1818910		ZL5C91000

Patients

Seq	Age	Sex	Outcome	Treatment
1	87 YR		Required Intervention