MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. FOUNDATION HIP; BIPOLAR SHELL, SZ 42

Catalog Number 412-01-042

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 02/03/2014

Event Type  Injury  

Event Description

Revision surgery - due to the bipolar cup and femoral head separating when reduction after the bipolar hip procdure operation was done.

Manufacturer Narrative

The reason for the revision surgery was the disengagement between the femoral head and the bipolar liner in the shell due to forces associated with closed reduction.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was returned djo surgical for examination/inspection.The cocrmo components (the ø22mm femoral head and the bipolar shell) are in generally pristine condition, with the exception of three or four very small scratches on the articulating surface of the bipolar shell.The bipolar liner was received still secured within the bipolar shell.The femoral head height was measured to be 0.691", within the required range of 0.693" ± 0.008".The head diameter was ø 0.871", inside the specification range of ø0.867" to ø0.875".The bipolar shell height was 0.9935", within the required range of 0.993" ± 0.005".The bipolar shell was ø1.653" in outer diameter, within the required ø1.654" ± ø0.005" range.The diameter of the inside edge of the bipolar liner was measured with a caliper in several locations, with results between ø0.838" and ø0.840".This diameter is the most relevant part dimension associated with retention of the femoral head in the bipolar liner, and the results fall within the required range of ø0.841" ± 0.003".A review of the device history records showed no non-conforming material reports associated with this product or the concomitant products.A review of the product complaint report history showed that since 2006 there are ten prior complaints against the bipolar modular shell / liner, part number 412-01-042.Nine of these are associated with dislocation or disassociation.This is the first complaint for the lot number of the incident bipolar modular shell / liner.There were eight prior complaints against the femoral head, part number 400-01-221.Five of these complaints are associated with dislocation in a bipolar system.This is the first complaint for the lot number of the incident femoral head.There are no prior complaints against the 427-41-105 revelation hip stem.The specific reason for the dissociation could not be determined with confidence.Two factors that may have played a role in dissociation are (1) insufficient tension in the surrounding soft tissue, and (2) variations in individual ranges of motion, primarily external rotation and flexion in combination with internal rotation.There was no information reported that evidences a material, design, or manufacturing problem with the product.

• Brand Name: FOUNDATION HIP
• Type of Device: BIPOLAR SHELL, SZ 42
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445 ; 5128346255
• MDR Report Key: 3655993
• MDR Text Key: 4321048
• Report Number: 1644408-2014-00112
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K953510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: 412-01-042
• Device Lot Number: 961B1049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/07/2014
• Initial Date FDA Received: 03/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: (B)(4); (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR