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

Model Number	425-96-011
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to patient being in pain and having an infection.
Additional Manufacturer Narrative
The reason for this revision surgery was an infection.The previous surgery and the revision detailed in this investigation occurred 8.8 months apart.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 associated with the components that may have contributed to pain or infection.The device and its applicable concomitant devices were verified to have gone through acceptable sterilization processes and were within their respective expiration dates at the time of use during the previous surgery.Customer complaint history of the reported 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 an infection.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the infection or inhibited the patient's immune system.There are multiple factors that may contribute to an infection that are outside of the control of djo surgical.There were no findings during this investigation that indicate that the reported device was the source of the pain or had a direct connection with the patient's infection.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, STANDARD, SIZE 11
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8289853
• Report Number: 1644408-2019-00070
• Device Sequence Number: 11378261
• Product Code: LPH
• UDI-Device Identifier: 00888912078566
• UDI-Public: (01)00888912078566
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K130099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2019

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: 08/28/2020
• Device Model Number: 425-96-011
• Device Catalogue Number: 425-96-011
• Device Lot Number: 190R1010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 02/05/2019
• 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: 400-03-402, LOT 871B1111; 430-99-056, LOT 607G1065; 932-40-756, LOT 815N1964; 400-03-402, LOT 871B1111; 430-99-056, LOT 607G1065; 932-40-756, LOT 815N1964
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR