FDA Adverse Event Injury Summary report: N

S-ROM*SLEEVE PRX ZTT, 22D-LRG

MDR report key: 2950483 · Received February 8, 2013

Report

Report Number: 1818910-2013-12046
Event Type: Injury
Date Received: February 8, 2013
Date of Event: January 25, 2013
Report Date: January 25, 2013
Manufacturer: DEPUY (IRELAND)
Product Code: LPH
PMA / PMN Number: PK934412
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: VA, 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

PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE SLEEVE AND STEM. SURGEON QUESTIONS BONE QUALITY AND SLIGHT UNDER-SIZING OF IMPLANTS, WHICH LED TO THE LOOSENING. DOI (B)(6) 2006 - DOR (B)(6) 2013 (LEFT HIP). 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. PER FOLLOW UP; PATIENT X-RAYS ARE NOT AVAILABLE FOR EXAMINATION. 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 AND LOOSENING OF THE SLEEVE AND STEM. SURGEON QUESTIONS BONE QUALITY AND SLIGHT UNDERSIZING OF IMPLANTS, WHICH LED TO THE LOOSENING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
54496	S-ROM*SLEEVE PRX ZTT, 22D-LRG	FEMORAL HIP STEM ACCESSORY	LPH	DEPUY (IRELAND)		1953687

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR		Required Intervention