MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. FMP HIP; LINER, MP 7

Catalog Number 432-28-007

Device Problems Material Integrity Problem (2978); Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 01/06/2014

Event Type  Other  

Event Description

Revision surgery - the pt presented with lateral poly wear of the acetabulum.The surgeon decided to do a poly swap and the hip was stable.The original surgery data could not be recovered.

Manufacturer Narrative

The reason for this revision surgery was identified as wear after 12.75 years of patient use.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the revision surgery.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 at the hospital and not made available to djo surgical for examination.A review of the device history records showed no non-conforming material reports associated with this product.(b)(4).The root cause for the revision was wear.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: FMP HIP
• Type of Device: LINER, MP 7
• 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: 3597156
• MDR Text Key: 4093122
• Report Number: 1644408-2014-00024
• Device Sequence Number: 1
• Product Code: KWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023794
• 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: 01/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2013
• Device Catalogue Number: 432-28-007
• Device Lot Number: 422201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/1998
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 82