MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. BIOLOX HIP; HEAD, FEMORAL,CERAMIC 32/-4

Catalog Number	400-01-295
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/08/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - the total hip implant failed; requiring this revision of a total hip.
Additional Manufacturer Narrative
The reason complaint was the patient had a hip system that failed as stated by the patient and was explanted after 7.8 years.There was no information submitted with the complaint that would indicate a material, design, or manufacturing issue(s) with the explanted part(s).The complaint reports no issues of any other patient injuries, activities, accidents or manufacturing contraindications that may have been contributory to this surgery.No reported pre-existing patient health conditions.The complaint does not report any surgical delays during the revision surgery.This complaint evaluation is limited in scope since the part (s) associated with this investigation was not returned to djo surgical for evaluation.A review of the device history records (dhrs) revealed no discrepancies or issues with the manufacturing history of this part.All critical dimensions and specifications in effect at the time the part was manufactured were met.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 root cause for the failure was not reported.The scope of this investigation is limited without having the parts available to djo surgical for evaluation.Other conditions, root cause, relating to this event could not be determined with confidence.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: BIOLOX HIP
• Common Device Name: HEAD, FEMORAL,CERAMIC 32/-4
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• MDR Report Key: 5963063
• Report Number: 1644408-2016-00750
• Device Sequence Number: 705177
• Product Code: LPH
• UDI-Device Identifier: 00888912075701
• UDI-Public: (01)00888912075701
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K955563
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2016

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: 07/31/2012
• Device Catalogue Number: 400-01-295
• Device Lot Number: 53867098
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2016
• Supplement Report FDA Received Date: 10/18/2016
• 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: 498-01-056,LOT 53866551; 498-32-056,LOT 53912992
• Outcome Attributed to Adverse Event: Required Intervention