FDA Adverse Event Injury Summary report: N

REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7

MDR report key: 2914013 · Received January 14, 2013

Report

Report Number: 0002249697-2013-00045
Event Type: Injury
Date Received: January 14, 2013
Date of Event: January 2, 2013
Report Date: January 2, 2013
Manufacturer: STRYKER ORTHOPAEDICS-MAHWAH
Product Code: MEH
PMA / PMN Number: K092561
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. (B)(4): NOT RETURNED TO MANUFACTURER.

Additional Manufacturer Narrative · 1

AN EVENT REGARDING REVISION SURGERY DUE TO ALTR INVOLVING A REJUVENATE MODULAR DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION WAS NOT PERFORMED AS NO DEVICES WERE RECEIVED. A DEVICE HISTORY REVIEW FOUND THAT THE DEVICES IN THE REPORTED LOT WERE ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE SUPER AND CHS 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 ALTR IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL. NO FURTHER INVESTIGATION IS REQUIRED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT HAS ADVERSE LOCAL TISSUE REACTION.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT HAS ADVERSE LOCAL TISSUE REACTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
20832	REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7	IMPLANT	MEH	STRYKER ORTHOPAEDICS-MAHWAH		MHT63H

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR		Required Intervention