MAUDE Adverse Event Report: ENCORE MEDICAL L.P SHELL, BIPOLAR, MODULAR, ENCORE, SIZE44; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number 412-02-044

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

Patient Problem Unspecified Infection (1930)

Event Date 02/13/2024

Event Type  Injury  

Event Description

Revision surgery - due to infection.

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2023-00316; 412-02-045, 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: SHELL, BIPOLAR, MODULAR, ENCORE, SIZE44
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• 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: 18874141
• MDR Text Key: 337310112
• Report Number: 1644408-2024-00261
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00888912077361
• UDI-Public: 00888912077361
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953510
• 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: 03/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 412-02-044
• Device Lot Number: 988B1252A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/13/2023
• 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: 497-28-035 LOT: 631C1396
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female