MAUDE Adverse Event Report: ENCORE MEDICAL L.P HEAD, UNIPOLAR, MODULAR, ENCORE SIZE50; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number	411-00-150
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - infection.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to previous report number 1644408-2021-00017; 411-00-153, s808 - infection, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: HEAD, UNIPOLAR, MODULAR, ENCORE SIZE50
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 19265621
• Report Number: 1644408-2024-00612
• Device Sequence Number: 7355884
• Product Code: KWL
• UDI-Device Identifier: 00888912076852
• UDI-Public: 00888912076852
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K973614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2024

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 Catalogue Number: 411-00-150
• Device Lot Number: 918B1051
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 411-00-350 LOT: 931B1985
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female