FDA Adverse Event Other Summary report: N

CORMET RESURFACING

MDR report key: 2992724 · Received March 1, 2013

Report

Report Number
9614209-2013-00004
Event Type
Other
Date Received
March 1, 2013
Date of Event
June 23, 2010
Report Date
February 14, 2013
Manufacturer
CORIN LTD
Product Code
NXT
PMA / PMN Number
K082525
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
UK
Reporter Occupation
NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). PATIENT NOTES, PATHOLOGY REPORTS, POST PRIMARY AND PRE-REVISION X-RAYS, EXPLANT AND REASON FOR REVISION HAVE BEEN REQUESTED.

Description of Event or Problem · 1

CORMET REVISION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
89444 CORMET RESURFACING NXT METAL ON METAL RE-SURFACING NXT CORIN LTD 179.254B JQTK

Patients

Seq Age Sex Outcome Treatment
1 68 YR Hospitalization ASSOCIATED CORMET HEAD: 179.048B, LOT JKXR