FDA Adverse Event Other Summary report: N

TURON SHOULDER

MDR report key: 2530339 · Received April 5, 2012

Report

Report Number
1644408-2012-00175
Event Type
Other
Date Received
April 5, 2012
Date of Event
March 27, 2012
Report Date
March 27, 2012
Manufacturer
ENCORE MEDICAL, L.P.
Product Code
HSD
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
NJ, US
Reporter Occupation
NOT APPLICABLE

Narratives

Description of Event or Problem · 1

REVISION SURGERY - THE PATIENT HAD AN UNSTABLE TOTAL SHOULDER. THE POSTERIOR WAS DISLOCATING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 TURON SHOULDER PRIMARY HUMERAL STEM HSD ENCORE MEDICAL, L.P. 458G1005

Patients

Seq Age Sex Outcome Treatment
1 57 YR Required Intervention (B)(4), LOT 878C1029| (B)(4), LOT 54003844