FDA Adverse Event Injury Summary report: N

REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8

MDR report key: 2930034 · Received January 25, 2013

Report

Report Number: 0002249697-2013-00289
Event Type: Injury
Date Received: January 25, 2013
Date of Event: January 9, 2013
Report Date: January 9, 2013
Manufacturer: STRYKER ORTHOPAEDICS-MAHWAH
Product Code: MEH
PMA / PMN Number: K092561
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MS, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE EVALUATED BY MFR: NOT RETURNED TO MANUFACTURER.

Additional Manufacturer Narrative · 1

THE PATIENT IS 66 INCHES IN HEIGHT. AN EVENT REGARDING REVISION DUE TO PAIN INVOLVING A REJUVENATE MODULAR DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED. REVIEW OF DEVICE HISTORY RECORDS FOUND THE DEVICES IN THE REPORTED LOT WERE ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT DATABASES SHOW THERE HAVE BEEN OTHER EVENTS FOR THE REPORTED LOT. SIMILAR EVENTS HAVE OCCURRED FOR THE CATALOG NUMBER AND PRODUCT FAMILY. THESE EVENTS WERE DETERMINED TO BE ASSOCIATED WITH RA 2012-067. VOLUNTARY RECALL RA 2012-067 WAS INITIATED FOR ABGII AND REJUVENATE MODULAR STEMS AND NECKS DUE TO THE POTENTIAL RISKS ASSOCIATED WITH THESE DEVICES. THE REPORTED REVISION DUE TO PAIN IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL.

Description of Event or Problem · 1

PT HAD REVISION HIP DUE TO PAINFUL HIP AND NOTIFICATION OF RECALL. SHE HAD A MODULAR REVISION HIP WITH MDM IMPLANTED.

Description of Event or Problem · 1

PT HAD REVISION HIP DUE TO PAINFUL HIP AND NOTIFICATION OF RECALL. SHE HAD A MODULAR REVISION HIP WITH MDM IMPLANTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
35659	REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8	IMPLANT	MEH	STRYKER ORTHOPAEDICS-MAHWAH		MJM2DJ

Patients

Seq	Age	Sex	Outcome	Treatment
1	72 YR		Required Intervention