FDA Adverse Event Injury Summary report: N

ACCOLADE (127 DEG) SIZE 5.5 ACCOLADE (127 DEG) SIZE 5.5

MDR report key: 3844235 · Received June 2, 2014

Report

Report Number: 0002249697-2014-02016
Event Type: Injury
Date Received: June 2, 2014
Date of Event: December 19, 2013
Report Date: May 8, 2014
Manufacturer: STRYKER ORTHOPAEDICS-MAHWAH
Product Code: MEH
PMA / PMN Number: K994366
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

AN EVENT REGARDING ALTR INVOLVING AN ACCOLADE (127 DEG) SIZE 5.5 WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW CONFIRMED NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE OF A LACK OF INFORMATION. FURTHER INFORMATION SUCH AS THE REPORTED DEVICE, MEDICAL RECORDS, AND X-RAYS ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING THE ROOT CAUSE.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem · 1

IT WAS REPORTED A REVISION SURGERY OCCURRED DUE TO A PSEUDOTUMOR AND A HIGH GRADE TEAR GLUTEUS MEDIUS. THE CO/CR LEVELS WERE IDENTIFIED TO BE 4.9/<1.

Description of Event or Problem · 1

IT WAS REPORTED A REVISION SURGERY OCCURRED DUE TO A PSEUDOTUMOR AND A HIGH GRADE TEAR GLUTEUS MEDIUS. THE CO/CR LEVELS WERE IDENTIFIED TO BE 4.9/<1.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
322285	ACCOLADE (127 DEG) SIZE 5.5 ACCOLADE (127 DEG) SIZE 5.5	IMPLANT	MEH	STRYKER ORTHOPAEDICS-MAHWAH		37588002

Patients

Seq	Age	Sex	Outcome	Treatment
1	72 YR		Hospitalization\| R