FDA Adverse Event Malfunction Summary report: N

ANGLED ACET INSERTR

MDR report key: 3884595 · Received June 19, 2014

Report

Report Number: 1818910-2014-21546
Event Type: Malfunction
Date Received: June 19, 2014
Date of Event: June 17, 2014
Report Date: June 17, 2014
Manufacturer: DEPUY ORTHOPAEDICS, INC. 1818910
Product Code: LXH
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: PHYSICIAN

Narratives

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.

Additional Manufacturer Narrative · 1

PREVIOUSLY A CORRECTIVE ACTION WAS IDENTIFIED FOR THIS FAILURE MODE WHEREBY A DESIGN CHANGE WAS IMPLEMENTED AND ROUTED ON ECO-193427 (DWG-106984) IN 2007 IN ORDER TO STRENGTHEN THE LOCKING CATCH. THE DESIGN VERIFICATION WAS COMPLETED AND ROUTED ON DVA-101743-FDE AND CONCLUDED THAT THERE ARE NO OUTSTANDING ACTIONS IDENTIFIED. THIS PRODUCT WAS MANUFACTURED TO THE REVISED DESIGN HOWEVER NO TREND IS IDENTIFIED AT THE CURRENT TIME. THE COMPLAINT SHALL BE CLOSED WITH A JUSTIFIED CONCLUSION IT WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

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

PLASTIC THUMB LOCK BROKE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
360277	ANGLED ACET INSERTR	HIP INSTRUMENT/TRIAL	LXH	DEPUY ORTHOPAEDICS, INC. 1818910		PC30404001

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR