FDA Adverse Event Injury Summary report: N

UNKNOWN_RECONSTRUCTIVE_PRODUCT

MDR report key: 2931873 · Received January 28, 2013

Report

Report Number: 0002249697-2013-00389
Event Type: Injury
Date Received: January 28, 2013
Date of Event: January 14, 2013
Report Date: January 14, 2013
Manufacturer: STRYKER ORTHOPAEDICS-MAHWAH
Product Code: MEH
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN REJUVENATE NECK. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO MANUFACTURER - FACILITY RELEASED TO PATIENT.

Additional Manufacturer Narrative · 1

AN EVENT REGARDING REVISION INVOLVING AN UNKNOWN REJUVENATE MODULAR DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED. REVIEW OF DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE REPORTED DEVICE WAS NOT PROPERLY IDENTIFIED. A SEARCH OF THE SUPER AND CHS COMPLAINT DATABASES COULD NOT BE PERFORMED AS THE REPORTED DEVICE WAS NOT PROPERLY IDENTIFIED. SIMILAR EVENTS HAVE OCCURRED FOR THE REJUVENATE MODULAR 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 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 METALLOSIS AT JUNCTURE OF MODULAR NECK CONNECTED TO THE HIP STEM.

Description of Event or Problem · 1

IT WAS REPORTED THAT METALLOSIS AT JUNCTURE OF MODULAR NECK CONNECTED TO THE HIP STEM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
37816	UNKNOWN_RECONSTRUCTIVE_PRODUCT	IMPLANT	MEH	STRYKER ORTHOPAEDICS-MAHWAH

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention