FDA Adverse Event Malfunction Summary report: N

RESTORATION ADM X3 INSERT FOR RESTORATION ADM CUP

MDR report key: 2181713 · Received July 22, 2011

Report

Report Number
2181713
Event Type
Malfunction
Date Received
July 22, 2011
Date of Event
April 20, 2011
Report Date
July 22, 2011
Manufacturer
STRYKER
Product Code
JDI
Product Problem
Yes
Report Source
User Facility report
Reporter Location
FL, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

THE PATIENT UNDERWENT LEFT TOTAL HIP REPLACEMENT DUE TO A HIP FRACTURE. THE PATIENT THEN UNDERWENT A LEFT HIP REVISION. ACCORDING TO THE SURGEON'S DISCHARGE SUMMARY, "THE PATIENT HAD BEEN NONCOMPLIANT WITH THE POSTOPERATIVE INSTRUCTIONS FROM THE DAY OF SURGERY AND DISLOCATED HIS HIP TWICE. HOWEVER, X-RAYS, SHOWED THAT WHEN THE HIP WAS REDUCED, AND IT APPEARED NOT TO BE A CONCENTRIC REDUCTION, WHICH SUGGESTED THAT THERE WAS A DISASSOCIATION OF THE POLYETHYLENE LINER. THE PATIENT UNDERWENT A REVISION SURGERY WITHIN APPROXIMATELY ONE MONTH OF ORIGINAL SURGERY,WHERE AT THE TIME OF SURGERY, THE HEAD AND LINER HAD DISASSOCIATED RESULTING IN THE CERAMIC BALL RUBBING AGAINST THE ACETABULAR LINER." NOTES FROM THE OPERATIVE REPORT: .."THE INCISION WAS EXTENDED SLIGHTLY DISTALLY AND SLIGHTLY PROXIMALLY AND THE GLUTEUS MAXIMUS SPLIT IN LINE WITH ITS FIBERS AND THERE WAS A SIGNIFICANT HEMATOMA IN THE SOFT TISSUES AND THE POLYETHYLENE ADM LINER WAS THEN READILY ENCOUNTERED IN THE SOFT TISSUES. THIS WAS REMOVED WITHOUT ANY INCIDENT AND CERAMIC BALL HAD SOME SCORING FROM ARTICULATES OF THE CERAMIC BALL AGAINST THE PATIENT SOCKET. THE ACETABULAR SOCKET WAS CAREFULLY INSPECTED AND IRRIGATED WITH THE VISUAL INSPECTION BY THE SURGEON AS WELL AS A PHYSICIAN ASSISTANT FROM MULTIPLE ANGLES. THERE WERE NO SIGNS OF ANY EXCORIATION VISUALLY MORE ON PALPATION." POST OP DIAGNOSIS: HEAD AND LINER DISASSOCIATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 RESTORATION ADM X3 INSERT FOR RESTORATION ADM CUP HIP LINER JDI STRYKER 28/52 34205501
2 BIOLOX DELTA CERAMIC V40 FEMORAL HEAD FEMORAL HEAD LPH STRYKER 28 MM 35789001

Patients

Seq Age Sex Outcome Treatment
1 67 YR