FDA Adverse Event Other Summary report: N

RSP SHOULDER

MDR report key: 3180048 · Received June 13, 2013

Report

Report Number: 1644408-2013-00329
Event Type: Other
Date Received: June 13, 2013
Date of Event: June 6, 2013
Report Date: June 6, 2013
Manufacturer: ENCORE MEDICAL, L.P.
Product Code: KWS
PMA / PMN Number: K051075
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE REASON FOR THIS REVISION SURGERY WAS IDENTIFIED AS DISLOCATION AFTER ONE YEAR OF PATIENT USE. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AND NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE (B)(4) COMPLAINT FOR THIS PRODUCT: ONE FOR A MISSING FEATURE, ONE BROKEN/CRACKED/DAMAGED DEVICE, TWO REVISIONS, 26 DUE TO DISLOCATION, TWO DUE TO PAIN, SIX DUE TO INFECTION, EIGHT DUE TO TRAUMA, ONE FOR DEVICE LOOSENING, 11 FOR STABILITY/POOR JOINT, AND SIX FOR DISSOCIATION. THIS IS THE SECOND COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE OF THE DISLOCATION WAS MOST LIKELY DUE TO THE PATIENT FALLING. THERE IS NO INDICATION OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

Description of Event or Problem · 1

REVISION SURGERY - THE PT HAS PARKINSON'S, HE FELL AND DISLOCATED HIS SHOULDER. THE SURGEON EXCHANGED THE GLENOID HEAD AND ZIMMER LINER, THERE WAS NO PRODUCT INVOLVEMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
269852	RSP SHOULDER	GLENOID HEAD W/RETAINING SCREW/NEUTRAL	KWS	ENCORE MEDICAL, L.P.		869C1071

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR		Required Intervention