MAUDE Adverse Event Report: ENCORE MEDICAL L.P HEAD, FEMORAL, CERAMIC, BILOX DELTA, 40MM NEUTRAL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 400-03-402

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

Patient Problem Unspecified Infection (1930)

Event Date 03/22/2024

Event Type  Injury  

Event Description

Revision surgery - due to infection.

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2021-00797; 400-03-401, 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, FEMORAL, CERAMIC, BILOX DELTA, 40MM 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: 19149667
• MDR Text Key: 340673649
• Report Number: 1644408-2024-00535
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00888912023306
• UDI-Public: 00888912023306
• 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: 04/19/2024

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: 400-03-402
• Device Lot Number: 871B1503
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/24/2023
• 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: 932-40-754 LOT: 017V1051
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female