MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. FMP HIP; LINER, ACETABULAR, NEUTRAL, FMP 28X0XMP6 CM

Catalog Number 431-28-106

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 06/01/2015

Event Type  Injury  

Event Description

Revision surgery - separation of the poly wear.

Manufacturer Narrative

The reason for this revision surgery was separation of the poly wear.The length of in vivo service was 11.8 years.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.Initial or prolonged hospitalization was required.The device was disposed of at the hospital and not made available to (b)(4) for examination.A review of the device history records showed no non-conforming material reports associated with the main contributor component listed in the complaint.A review of the product complaint report history showed there have been 2 prior complaints reported against this part; 1 for wear and a second for dislocation.This is the first complaint against this lot number.The surgeon reported no issues associated with the explanted product other than normal wear after an extended period of time.The agent was contacted concerning the report of separation: this comment referred to the condition of the insert and its relationship to the hip shell ( wear causing stability issues), not separation or oxidation of the poly.No other conditions relating to this event could be determined with confidence.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: FMP HIP
• Type of Device: LINER, ACETABULAR, NEUTRAL, FMP 28X0XMP6 CM
• 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: 4828457
• MDR Text Key: 16181098
• Report Number: 1644408-2015-00345
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2015

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: 05/31/2006
• Device Catalogue Number: 431-28-106
• Device Lot Number: 699721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2015
• Initial Date FDA Received: 06/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2001
• 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): Hospitalization; Required Intervention