MAUDE Adverse Event Report: ENCORE MEDICAL L.P HEAD, FEMORAL, CERAMIC, BILOX DELTA, 36MM NEUTRAL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 400-03-362

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Dislocation (2374)

Event Date 04/01/2024

Event Type  Injury  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Event Description

Revision surgery - due to dislocation.

• Brand Name: HEAD, FEMORAL, CERAMIC, BILOX DELTA, 36MM NEUTRAL
• Type of Device: 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: 19218412
• MDR Text Key: 341457045
• Report Number: 1644408-2024-00586
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00888912076135
• UDI-Public: 00888912076135
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082844
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/30/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 400-03-362
• Device Lot Number: 866B2158
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 940-00-030 LOT: 147Z1193; 940-02-54G LOT: 801Z1285; 941-01-36G LOT: 599Z1143
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female