MAUDE Adverse Event Report: ENCORE MEDICAL L.P LINER 10 DEG. HOODED NEU, MP7, HXE-PLUS, 36MM; HIP PROSTHESIS, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER, + ADDITIVE, POROUS

Catalog Number 932-36-752

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

Patient Problem Insufficient Information (4580)

Event Date 09/25/2023

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 - locking bolt broke.

Manufacturer Narrative

This supplemental reporte was created due to the complaint has been reassessed and determined to be not reportable due to the part is unknown.

• Brand Name: LINER 10 DEG. HOODED NEU, MP7, HXE-PLUS, 36MM
• Type of Device: HIP PROSTHESIS, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER, + ADDITIVE, 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: 17981434
• MDR Text Key: 326234718
• Report Number: 1644408-2023-01472
• Device Sequence Number: 1
• Product Code: OQG
• UDI-Device Identifier: 00888912100168
• UDI-Public: 00888912100168
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130365
• 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: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 932-36-752
• Device Lot Number: 813N2111
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male