MAUDE Adverse Event Report: ENCORE MEDICAL L.P. HEAD, FEMORAL, CERAMIC, BILOX DELTA OPTION HEAD, 28MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	400-04-280
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to patient fell.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to previous report number 1644408-2020-00805 ;400-04-360, s809 - trauma, revision surgery if additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: HEAD, FEMORAL, CERAMIC, BILOX DELTA OPTION HEAD, 28MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: 19640121
• Report Number: 1644408-2024-00983
• Device Sequence Number: 12960051
• Product Code: LZO
• UDI-Device Identifier: 00888912076234
• UDI-Public: 00888912076234
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K082844
• 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): 06/28/2024

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: 400-04-280
• Device Lot Number: 881B1128
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 06/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2024
• 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: 400-05-300 LOT: 889B1295; 425-92-009 LOT: 4389A1010; 951-01-38D LOT: 2215A1084; 952-28-38D LOT: 2223A1104A
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown