FDA Adverse Event Injury Summary report: N

UNKNOWN DEPUY ACETABULAR LINER

MDR report key: 3230011 · Received July 16, 2013

Report

Report Number: 1818910-2013-21344
Event Type: Injury
Date Received: July 16, 2013
Date of Event: June 24, 2013
Report Date: June 24, 2013
Manufacturer: 1818910 DEPUY ORTHOPAEDICS, INC.
Product Code: HRY
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MD, 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

THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODE REQUIRED FOR THE HEAD WAS NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED FOR THE INSERT WAS UNAVAILABLE. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. 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.

Description of Event or Problem · 1

PATIENT WAS REVISED TO ADDRESS DISLOCATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
329681	UNKNOWN DEPUY ACETABULAR LINER	ACETABULAR LINER	HRY	1818910 DEPUY ORTHOPAEDICS, INC.		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR		Required Intervention