FDA Adverse Event Injury Summary report: N

ARTICULEZE M HEAD 36MM +5

MDR report key: 3001599 · Received March 13, 2013

Report

Report Number: 1818910-2013-13717
Event Type: Injury
Date Received: March 13, 2013
Date of Event: March 5, 2013
Report Date: March 5, 2013
Manufacturer: DEPUY INTL., LTD. 8010379
Product Code: JDI
PMA / PMN Number: PK980513
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WA, 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 PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. 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 PAIN AND ION LEVELS (COBALT = 4.7; CHROMIUM = 4.2). IT WAS NOTED THAT THE PATIENT HAS A COMPETITOR'S METAL-ON-METAL HIP IMPLANT ON HER RIGHT SIDE, AND THAT SHE HAS CHRONIC KIDNEY DISEASE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
105330	ARTICULEZE M HEAD 36MM +5	FEMORAL HEAD	JDI	DEPUY INTL., LTD. 8010379		3172358

Patients

Seq	Age	Sex	Outcome	Treatment
1	57 YR		Required Intervention