FDA Adverse Event Injury Summary report: N

C-STEM SIZE 4 PRIMARY

MDR report key: 1923677 · Received December 9, 2010

Report

Report Number: 1818910-2010-09905
Event Type: Injury
Date Received: December 9, 2010
Date of Event: September 24, 2010
Report Date: October 11, 2010
Manufacturer: DEPUY INTERNATIONAL, LTD.
Product Code: JDI
PMA / PMN Number: K982918
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

FRACTURE OF THE REPORTED DEVICE IS CONFIRMED. EXAMINATION OF THE RETURNED DEVICES AND PATIENT X-RAYS BY DEPUY INTERNATIONAL DID NOT REVEAL ANY RELATED PRODUCT PROBLEMS, MANUFACTURING DEVIATIONS OR ANOMALIES. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. THE INVESTIGATION CAN DRAW NO CONCLUSIONS REGARDING THE REPORTED EVENT. ALTHOUGH, INVESTIGATION FINDS IT MAY BE THAT THE PATIENT WEIGHT WAS A CONTRIBUTORY FACTOR. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. MONITOR THROUGH TREND ANALYSIS. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE 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

REVISION DUE TO BROKEN C STEM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	C-STEM SIZE 4 PRIMARY	87JDI; 87LZO; 87LZN	JDI	DEPUY INTERNATIONAL, LTD.	NA	YMN-66

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR		Required Intervention