MAUDE Adverse Event Report: ENCORE MEDICAL L.P LINER, ACETABULAR, NEUTRAL, FMP 28X0XMP10 CM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 431-28-110

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

Patient Problem Implant Pain (4561)

Event Date 03/20/2024

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 pain.

Manufacturer Narrative

See d4 expiration date, h4 and h11.Complaint has been evaluated and is similar to previous report number 1644408-2018-00352; 436-28-007, s807 - pain, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: LINER, ACETABULAR, NEUTRAL, FMP 28X0XMP10 CM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS 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: 19149676
• MDR Text Key: 340673953
• Report Number: 1644408-2024-00520
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00888912084444
• UDI-Public: 00888912084444
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974093
• 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: 431-28-110
• Device Lot Number: 697571
• 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
• 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: 497-28-000 LOT: 968401
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male