MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. FMP HIP; LINER/NON-HOODED-NEU, MP10, HXE-PLUS, 44MM

Catalog Number 931-44-760

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 03/04/2016

Event Type  Injury  

Event Description

Revision surgery - due to the patient dislocating.

Manufacturer Narrative

The reason for this revision surgery was hip dislocation.The length of the in-vivo service was 2.4 months.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 a serious risk to the patient.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 (b)(4) for examination.A review of the device history records (dhrs) revealed no discrepancies or issues with the manufacturing history of this part.All parts were found to meet design and manufacturing specifications.No non-conforming material reports (ncmr's) were associated with this part.The product complaint report history was reviewed and no trends or on-going issues were deemed as present or in need of review.This event is deemed to be non-product related.The surgeon reported no issues associated with the explanted product and provided no information that definitively described the root cause or reason of the dislocation.The scope of this investigation is limited without having the parts available to (b)(4)for evaluation.Other conditions relating to this event could not be determined with confidence.Factors that may contribute to a dislocation not associated with the implant are: improper implant selection, degenerative bone disease, and improper surgical technique.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: FMP HIP
• Type of Device: LINER/NON-HOODED-NEU, MP10, HXE-PLUS, 44MM
• 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: 5531713
• MDR Text Key: 41366235
• Report Number: 1644408-2016-00219
• Device Sequence Number: 1
• Product Code: OQH
• UDI-Device Identifier: 00888912099936
• UDI-Public: (01)00888912099936
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130365
• 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: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 931-44-760
• Device Lot Number: 764N1002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2014
• 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): Other; Required Intervention
• Patient Age: 74 YR