MAUDE Adverse Event Report: ENCORE MEDICAL L.P LINER, ACETABULAR, HOODED, NEUTRAL, 20°, HXL/FMP, 28MM ID, MP5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 933-28-248

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

Patient Problem Joint Laxity (4526)

Event Date 03/12/2024

Event Type  Injury  

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2022-00116; 933-28-748, s805 - wear/excessive wear, 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 worn poly.

• Brand Name: LINER, ACETABULAR, HOODED, NEUTRAL, 20°, HXL/FMP, 28MM ID, MP5
• 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: 19093731
• MDR Text Key: 339983057
• Report Number: 1644408-2024-00454
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00888912100540
• UDI-Public: 00888912100540
• 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
• Report Date: 04/11/2024

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 Expiration Date: 06/28/2018
• Device Catalogue Number: 933-28-248
• Device Lot Number: 767F1009
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/17/2013
• 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: 631C1151
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female