MAUDE Adverse Event Report: ENCORE MEDICAL L.P. TAPERFILL HIP; TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 11

Catalog Number	425-97-011
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/27/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - the patient subsided about 6 weeks post-operation; the bone quality is poor.Due to soft bone, the patient needed to be revised to a larger and longer stem.
Additional Manufacturer Narrative
The reason for this revision surgery was the patient's hip stem subsided.The in-vivo length of patient service for the implant was 2.6 months.The healthcare professional indicated there was a significant adverse event/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 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 event is deemed as non-product related.The root cause for the patient's hip stem subsiding was reported as the result of the patient having poor bone quality.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: TAPERFILL HIP
• Common Device Name: TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 11
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6343156
• Report Number: 1644408-2017-00091
• Device Sequence Number: 603000
• Product Code: LPH
• UDI-Device Identifier: 00888912078696
• UDI-Public: (01)00888912078696
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K130099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2017

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: 05/10/2022
• Device Catalogue Number: 425-97-011
• Device Lot Number: 176R1934
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2017
• Supplement Report FDA Received Date: 04/12/2017
• 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: 411-00-700,LOT 932B1919; 497-36-000,LOT 638C1198
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 89 YR