MAUDE Adverse Event Report: ENCORE MEDICAL L.P HIP, STEM, CLP, STANDARD, SIZE#8, IMPLANT, POLISHED NECK; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number 426-10-080

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

Patient Problem Implant Pain (4561)

Event Date 12/18/2023

Event Type  Injury  

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2020-01181; 426-00-020, s807 - pain, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

Event Description

Revision surgery - due to pain.

• Brand Name: HIP, STEM, CLP, STANDARD, SIZE#8, IMPLANT, POLISHED NECK
• 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: 18509296
• MDR Text Key: 332869885
• Report Number: 1644408-2023-01986
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00888912079563
• UDI-Public: 00888912079563
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932481
• 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: 01/12/2024

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: 426-10-080
• Device Lot Number: 408N1039
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2020
• 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: 400-03-402 LOT: 871B1296.; 941-01-40H LOT: 605Z1068.
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male