FDA Adverse Event Injury Summary report: N

UNKNOWN_RECONSTRUCTIVE_PRODUCT

MDR report key: 2934625 · Received January 30, 2013

Report

Report Number: 0002249697-2013-00452
Event Type: Injury
Date Received: January 30, 2013
Date of Event: January 9, 2013
Report Date: January 9, 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

AN EVENT REGARDING METALLOSIS INVOLVING AN UNKNOWN REJUVENATE MODULAR DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION WAS NOT PERFORMED AS NO DEVICES WERE RECEIVED. A REVIEW OF DEVICE HISTORY RECORDS 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. NO FURTHER INVESTIGATION IS REQUIRED.

Additional Manufacturer Narrative · 1

CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN REJUVENATE NECK AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED TO THE MANUFACTURER.

Description of Event or Problem · 1

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

Description of Event or Problem · 1

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

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
41306	UNKNOWN_RECONSTRUCTIVE_PRODUCT	IMPLANT	MEH	STRYKER ORTHOPAEDICS-MAHWAH

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention