UNKNOWN DEPUY LINER

Report

Report Number: 1818910-2013-10012
Event Type: Injury
Date Received: January 2, 2013
Date of Event: December 12, 2012
Manufacturer: DEPUY ORTHOPAEDICS, INC.
Product Code: KWA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, 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

IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. PATIENT WAS REVISED TO ADDRESS CONTINUAL DISLOCATION. DOI (B)(6) 2000 - DOR (B)(6) 2012 (LEFT HIP). UPDATE 1/14/2013 - MEDICAL RECORDS AND X-RAYS WERE RECEIVED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. C. MEDICAL RECORDS AND X-RAYS WERE OBTAINED. THE REPORTED DISLOCATION IS CONFIRMED BUT ROOT CAUSE NOT IDENTIFIED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

Description of Event or Problem · 1

PATIENT WAS REVISED TO ADDRESS CONTINUAL DISLOCATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1701	UNKNOWN DEPUY LINER	ACETABULAR LINER	KWA	DEPUY ORTHOPAEDICS, INC.		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Required Intervention