FDA Adverse Event Injury Summary report: N

PINNACLE MULTIHOLE II CUP 50MM

MDR report key: 2881589 · Received December 20, 2012

Report

Report Number: 1818910-2012-83990
Event Type: Injury
Date Received: December 20, 2012
Date of Event: December 13, 2012
Report Date: December 13, 2012
Manufacturer: DEPUY ORTHOPAEDICS, INC.
Product Code: LPH
PMA / PMN Number: PK000306
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CO, 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 DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. C. 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.

Description of Event or Problem · 1

PATIENT WAS REVISED TO ADDRESS PAIN. SURGEON WAS UNDER THE IMPRESSION THAT THE PATIENT'S PAIN WAS DUE TO METAL-ON-METAL; HOWEVER, WHEN THE SURGEON REMOVED THE LINER, HE NOTICED THAT THE CUP WAS LOOSE, AND THAT THERE WAS NO INGROWTH ON THE CUP.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PINNACLE MULTIHOLE II CUP 50MM	ACETABULAR CUP	LPH	DEPUY ORTHOPAEDICS, INC.		B65EM1000

Patients

Seq	Age	Sex	Outcome	Treatment
1	51 YR		Required Intervention