MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP CC TRIO 01.26.3244HCT FLAT PE HC LINER Ø 32 / E; HIP FLAT PE HC LINER

Model Number	01.26.3244HCT
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery at about 8 years and 3 months post primary, revision surgery for hip luxation.Liner and head revised successfully.
Additional Manufacturer Narrative
Batch review performed on 14 june 2023: lot 147762: 130 items manufactured and released on 12-feb-2015.Expiration date: 2019-12-31.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event in the period of review.Clinical evaluation performed by medical affairs department: revision surgery about 8 years and 3 months post primary tha, due to hip luxation.Liner and head revised successfully.From the radiographic image no additional info are visible.Since the implant remained intact for all these years, dislocation may have been caused by a specific event that was not reported, such as trauma or extreme position.Therefore, this can hardly be caused by a defect or malfunction of the implanded devices.Other device involved (not distributed in us): implants from ceramtec 38.49.7175.675.00 biolox delta ceramic ball head 12/14 ø 32 size m 0 lot.7010943251: based on the number provided, the component at issue could be identified as ceramtec component.Protocols and certificate of conformance were reviewed.The quality documents (including the sterilisation certificates) show that the data obtained on the femoral head conformed to the specification valid at the time of production.· the component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There is no indication of any preexisting material defect or non-conformities regarding sterilisation.· due to the fact that the femoral head at issue was not provided, ceramtec could not carry out any further investigations.

• Brand Name: LINER: VERSAFITCUP CC TRIO 01.26.3244HCT FLAT PE HC LINER Ø 32 / E
• Common Device Name: HIP FLAT PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17265750
• Report Number: 3005180920-2023-00494
• Device Sequence Number: 5960014
• Product Code: LZO
• UDI-Device Identifier: 07630030807572
• UDI-Public: 07630030807572
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• 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): 07/06/2023

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: 12/31/2019
• Device Model Number: 01.26.3244HCT
• Device Catalogue Number: 01.26.3244HCT
• Device Lot Number: 147762
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 75 KG