PIN LINER CONST NEUT 50ODX28ID

Report

Report Number: 1818910-2013-15266
Event Type: Injury
Date Received: April 11, 2013
Date of Event: April 2, 2013
Report Date: April 2, 2013
Manufacturer: DEPUY ORTHOPAEDICS
Product Code: KWZ
PMA / PMN Number: PK043058
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: 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

VISUAL EXAMINATION OF THE RETURNED DEVICES FINDS EVIDENCE TO SUPPORT DISASSOCIATION OF THE LINER AND CUP WHILE IMPLANTED. THE FEMORAL HEAD SHOWS SIGNS OF CONTACT WITH THE ACETABULAR COMPONENT. EVIDENCE FOUND ON THE LINER RING CONFIRMS STEM IMPINGEMENT. LIMITED PATIENT DEMOGRAPHICS WERE RECEIVED, ACTIVITY LEVEL WAS NOT REPORTED. A SEARCH OF THE COMPLAINTS DATABASES FINDS ONE OTHER REPORT AGAINST THE D5DDN1 LOT CODE FOR DISLOCATION. NO OTHER REPORTS WERE FOUND AGAINST THE 3241332 LOT CODE. REVIEW OF DEVICE HISTORY RECORDS FINDS NO MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. X-RAY CONFIRMS THAT THE RING DISASSOCIATED FROM THE DEVICE IN VIVO. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

Description of Event or Problem · 1

THE SURGEON PERFORMED A NEW OPERATION TO REMOVE THE BROKEN CONSTRAINED INSERT

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
156011	PIN LINER CONST NEUT 50ODX28ID	ACETABULAR LINER	KWZ	DEPUY ORTHOPAEDICS		D5DDN1000

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR		Required Intervention