MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. X-ALT HIP; LINER, ACETABULAR, HOODED, NEUTRAL, 20°, HXL/FMP, 36MM ID, MP7

Catalog Number	933-36-252
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/15/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the liner not being in place; it kept displacing the hip.
Additional Manufacturer Narrative
The reason for this revision surgery was the patient's hip kept displacing.The length of in vivo service was 1.8 months.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 (b)(4) prior complaints reported against this part number; summary of investigations: 1 dislocation, 1 instability, 1 device looseness, 1 infection.This is the first complaint against this lot number.The complaint states liner was not in place without any further explanation.The surgeon reported no issues associated with the explanted product and provided no information that definitively described the root cause or reason of the joint dislocation.No other conditions relating to this event could be determined with confidence.Factors that may contribute to joint dislocation that are not associated with the implants are: improper implant selection, degenerative bone disease, patient non-compliance with medical instructions.This investigation produced no indications or suggestions of a product or process issue affecting implant safety or effectiveness.

• Brand Name: X-ALT HIP
• Common Device Name: LINER, ACETABULAR, HOODED, NEUTRAL, 20°, HXL/FMP, 36MM ID, MP7
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• MDR Report Key: 5367508
• Report Number: 1644408-2016-00001
• Device Sequence Number: 87315
• Product Code: OQG
• UDI-Device Identifier: 00888912100618
• UDI-Public: (01)00888912100618
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K130365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Followup
• Report Date (Section B): 12/15/2015

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 933-36-252
• Device Lot Number: 771F1036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2016
• Supplement Report FDA Received Date: 05/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention