MAUDE Adverse Event Report: ENCORE MEDICAL L.P SLEEVE, UNIPOLAR, OFFSET +10.5; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number 411-00-105

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

Patient Problem Foreign Body In Patient (2687)

Event Date 01/05/2024

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 metallosis.

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number: 1644408-2018-00857; 499-34-007, s800 - revision surgery, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: SLEEVE, UNIPOLAR, OFFSET +10.5
• Type of Device: 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
• MDR Report Key: 18628614
• MDR Text Key: 334367559
• Report Number: 1644408-2024-00058
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00888912076722
• UDI-Public: 00888912076722
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040354
• 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,Followup
• Report Date: 03/28/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 411-00-105
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2010
• 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: 411-00-105 LOT: UNKNOWN.; 430-01-004 LOT: 992871.; 497-38-000 LOT: UNKNOWN.; 499-38-011 LOT: 243562.
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male