FDA Adverse Event Injury Summary report: N

UNKNOWN DEPUY TIBIAL INSERT

MDR report key: 2113360 · Received May 20, 2011

Report

Report Number: 1818910-2011-08947
Event Type: Injury
Date Received: May 20, 2011
Date of Event: April 20, 2011
Report Date: April 20, 2011
Manufacturer: DEPUY ORTHOPAEDICS, INC.
Product Code: JWH
PMA / PMN Number: NA
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER

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

REOPENED AS PRODUCT WAS RECEIVED. EXAMINATION OF THE RETURNED TIBIAL INSERTS BY A DEPUY (B)(4) POLYMER RESEARCH SCIENTIST CONFIRMED THE WEAR. THE WEAR CONTRIBUTED THE VOLUMETRIC LOSS ON THE ARTICULATING SURFACE. THE WEAR PATTERN ON THE ARTICULATING SURFACES INDICATES THE PREFERENTIAL LOADING OF THE JOINT. THE OBSERVED AMOUNT OF WEAR IS TYPICAL FOR NON-CROSSLINKED POLY INSERTS. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE ONE PROVIDED LOT NUMBER A2YET1 FOUND NO MANUFACTURING DEVIATIONS OR ANOMALIES. THE INSPECTION RECORDS WERE ALSO REVIEWED FOR THE RAW MATERIAL LOT AND FOUND NO MANUFACTURING DEVIATIONS OR RELATED REJECTIONS. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS 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 REVISED FOR POLYETHYLENE WEAR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	UNKNOWN DEPUY TIBIAL INSERT	TOTAL EXTREMITY REPLACEMENT	JWH	DEPUY ORTHOPAEDICS, INC.	NA	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	59 YR		Required Intervention