MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. FMP HIP; SHELL, FMP HEMISPHERICAL SIZE44 W/HOLES

Catalog Number	430-01-044
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/12/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - the primary hip surgery was performed on (b)(6) 2006.Due to radiolucent pockets behind the acetabular cup causing screw loosening, micromotion, and pain.The cup was revised to a larger depuy cup with a 32mm cocr neutral head on the well fixed stem.
Additional Manufacturer Narrative
The reason for this revision surgery was the screws had loosened, creating micromotion and joint pain.The in-vivo length of service for the patient's implant was 10.4 years.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 device history records (dhrs) revealed no discrepancies or issues with the manufacturing 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 surgery has been determined to be non-product related.The root cause of this event was reported as radiolucency pockets behind the acetabular cup causing the screws to loosen, and creating micromotion and joint pain.The scope of this investigation is limited without having the parts available to djo surgical for evaluation.Other conditions relating to this event could not be determined with confidence.Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: FMP HIP
• Common Device Name: SHELL, FMP HEMISPHERICAL SIZE44 W/HOLES
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• MDR Report Key: 6010933
• Report Number: 1644408-2016-00744
• Device Sequence Number: 10898066
• Product Code: LPH
• UDI-Device Identifier: 00888912081771
• UDI-Public: (01)00888912081771
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K974093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2016

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: 08/31/2010
• Device Catalogue Number: 430-01-044
• Device Lot Number: 389751C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/07/2016
• Supplement Report FDA Received Date: 11/11/2016
• 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: 010-55-020, LOT 259262E; 010-55-020, LOT 266482D; 400-01-221, LOT 289362; 432-22-203, LOT 288052
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR