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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/12/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Revision surgery - due to worn poly.

• Brand Name: LINER, ACETABULAR, HOODED, NEUTRAL, 20°, HXL/FMP, 28MM ID, MP5
• Common Device Name: 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
• Report Number: 1644408-2024-00454
• Device Sequence Number: 7840234
• Product Code: LPH
• UDI-Device Identifier: 00888912100540
• UDI-Public: 00888912100540
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2018
• Device Catalogue Number: 933-28-248
• Device Lot Number: 767F1009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 497-28-035 LOT: 631C1151
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female