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

Model Number	01.26.3244HCT
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 january 2022.Lot 154196: (b)(4) items manufactured and released on 23-nov-2015.Expiration date:2020-nov-02.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event.Clinical evaluation performed by medical affairs director: 6 years after primary tha on an (b)(6) old patient, revision is required due to luxation of the prosthesis.No traumatic event has been reported.During revision, the original cup has been removed and exchanged with a larger size one.Luxation with a standard, well proven device is normally due to suboptimal component positioning or insufficient soft tissue tension.Since many years have passed without any adverse event reported, a plausible cause of the adverse event could be the progressive laxity of the soft tissues, a standard consequence of aging.The radiographic images provided do not show additional information.Additional items involved in the event, batch review performed on 27 january 2022: external supplier analysis: implants from ceramtec 38.49.7175.685.00 biolox delta ceramic ball head 12/14 ø 32 size l +4 lot.7010891849 (item not registered in usa) 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 pre-existing material defect or non-conformities regarding sterilisation.
Event or Problem Description
Luxated hip prosthesis.Revision surgery performed 5 years and 11 months after the primary surgery.Head and liner revised.

• Brand Name: LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 32 / E
• Common Device Name: FLAT PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13558377
• Report Number: 3005180920-2022-00115
• Device Sequence Number: 3734671
• 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: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2022

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: 11/02/2020
• Device Model Number: 01.26.3244HCT
• Device Catalogue Number: 01.26.3244HCT
• Device Lot Number: 154196
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/23/2015
• 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 Sex: Female
• Patient Weight: 68 KG