MAUDE Adverse Event Report: ENCORE MEDICAL L.P. X-ALT HIP; LINER/10 DEGREE HOODED-NEU, MP5, HXE-PLUS, 28MM

Catalog Number	932-28-748
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/10/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery.The doctor decided that the patient wasn't stable enough and wanted to constrain.
Additional Manufacturer Narrative
The reason for this revision surgery was instability.The previous surgery and the revision detailed in this investigation occurred over 1 year and 5 months apart.There are no reported pre-existing patient health conditions.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.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhr) shows that the reported components used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to hip instability.The device was within it's respective expiration date at the time of use during the previous surgery.Customer complaint history of the device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to patient's instability.There are multiple factors which may cause the event that are outside the control of djo surgical are degenerative bone, poor bone density, patient bone deterioration, improper surgical technique or implant selection.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any activities that may have contributed to the event and hence a definitive root cause cannot be determined.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: X-ALT HIP
• Common Device Name: LINER/10 DEGREE HOODED-NEU, MP5, HXE-PLUS, 28MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6298812
• Report Number: 1644408-2017-00059
• Device Sequence Number: 16420415
• Product Code: OQG
• UDI-Device Identifier: 00888912100021
• UDI-Public: (01)00888912100021
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2017

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: 05/31/2020
• Device Catalogue Number: 932-28-748
• Device Lot Number: 810N1906
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 04/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 497-28-700, LOT 635G1117
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR