FDA Adverse Event Injury Summary report: N

PINN LNR CON +4 NEUT 32IDX52OD

MDR report key: 2955189 · Received February 11, 2013

Report

Report Number: 1818910-2013-12131
Event Type: Injury
Date Received: February 11, 2013
Date of Event: January 29, 2013
Report Date: January 30, 2013
Manufacturer: DEPUY ORTHOPAEDICS, INC.
Product Code: KWZ
PMA / PMN Number: PK043058
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE FEMORAL HEAD'S PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORD FOR THE ACETABULAR LINER DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. 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. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR 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

PATIENT WAS REVISED TO ADDRESS DISLOCATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
58089	PINN LNR CON +4 NEUT 32IDX52OD	ACETABULAR LINER	KWZ	DEPUY ORTHOPAEDICS, INC.		140944

Patients

Seq	Age	Sex	Outcome	Treatment
1	50 YR		Required Intervention