FDA Adverse Event Other Summary report: N

LIMA HIP INSTRUMENT

MDR report key: 3254167 · Received July 25, 2013

Report

Report Number: 1644408-2013-00387
Event Type: Other
Date Received: July 25, 2013
Date of Event: July 11, 2013
Report Date: July 11, 2013
Manufacturer: ENCORE MEDICAL, L.P.
Product Code: JDI
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NV, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS BOTH SCREWS FAILING TO ENGAGE WITH THE FEMORAL STEM. THERE WAS A 30 MINUTE DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS RETURNED TO DJO SURGICAL FOR EXAMINATION. EXAMINATION OF THE RETURNED LATERAL NECK, H70 SHOW THE LEAD THREADS OF THE LOCKING SCREW ARE STRIPPED WHICH MAY HAVE CAUSED THE ENGAGEMENT OF THE STEM TO FAIL. THE REPORTED PROBLEM COULD POSSIBLY BE A RESULT OF HEAVY USE, MISUSE OR WEAR. CARE MUST BE TAKEN TO AVOID COMPROMISING THEIR PERFORMANCE, REFER TO INSTRUMENT INSTRUCTIONS FOR USE (IFU) 0400-0146 FOR RECOMMENDATIONS FOR THE CARE AND HANDLING OF DJO INSTRUMENTS. (B)(4). THE ROOT CAUSE FOR THIS EVENT IS ATTRIBUTABLE TO DAMAGE INCURRED FROM PROLONGED USE AND THROUGH MISUSE OR ROUGH HANDLING OF THE SURGICAL INSTRUMENTS. THIS EVENT IS NOT ASSOCIATED WITH A PRODUCT FAILURE, MISUSE, OR OTHER ISSUE.

Description of Event or Problem · 1

REVISION SURGERY - DURING THE REVISION SURGERY, THE INSTRUMENT FAILED DUE TO THE SCREWS IN BOTH THE 70MM STANDARD AND THE 70MM LATERAL LIMA NECK TRIALS FAILING TO ENGAGE WITH THE FEMORAL STEM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
347837	LIMA HIP INSTRUMENT	LAT TRIAL NECK, H70	JDI	ENCORE MEDICAL, L.P.		80002L08

Patients

Seq	Age	Sex	Outcome	Treatment
1	60 YR		Required Intervention