FDA Adverse Event Injury Summary report: N

ELITE MODULAR HEAD 22MM -3

MDR report key: 2033718 · Received March 17, 2011

Report

Report Number: 1818910-2011-04204
Event Type: Injury
Date Received: March 17, 2011
Report Date: February 15, 2011
Manufacturer: DEPUY INTERNATIONAL, LTD.
Product Code: JDI
PMA / PMN Number: K871867
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

EXAMINATION OF THE RETURNED PATIENT X-RAYS AND REPORTED DEVICES CONFIRMS THE REPORTED DISLOCATION; ALTHOUGH THE ROOT CAUSE OF THE DISLOCATION CANNOT BE CONFIRMED. IT WAS STATED IN THE INITIAL REPORTING THERE IS A HIGH PROBABILITY THE DISLOCATION OCCURRED DURING DISLOCATION REDUCTION. A REVIEW OF THE DEVICE HISTORY RECORDS BY DEPUY INTERNATIONAL FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE EVENT. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION 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

AFTER IMPLANTATION, DISLOCATION OF THE CUP OUT OF INNER HEAD WAS NOTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ELITE MODULAR HEAD 22MM -3	87 JDI	JDI	DEPUY INTERNATIONAL, LTD.	NA	3174020

Patients

Seq	Age	Sex	Outcome	Treatment
1	84 YR		Required Intervention