MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP 01.26.2848MHC DOUBLE MOBILITY HC LINER Ø 48/28; HIP DOUBLE MOBILITY HC LINER

Model Number	01.26.2848MHC
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 june 2023: lot: 180667: (b)(4) items manufactured and released on 17-may-2018.Expiration date: 2023-05-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Clinical evaluation performed by medical affairs director: revision surgery 4 years and 4 months after primary tha due to hip instability.According to report, it was reported posterior subluxation at 50 degree hip flexion, 10 degree adduction and beyond 45 degrees of internal rotation due to bone to bone impingement anteriorly.From the preop image, the stem looks slightly undersized.The reason of this choice cannot be assessed on the basis of a single anteroposterior radiographic projection.From the post-op radiographic image, a (presumably) intraoperative fracture solved with cerclage is visible but no information was given regarding this event.With the information at hand, the reason of this failure cannot be determined.Other device involved: cup: versafitcup 01.26.48mb acetabular shell ø 48 (k083116) lot: 178346: (b)(4) items manufactured and released on 14-mar-2018.Expiration date: 2023-03-04.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.
Event or Problem Description
Revision surgery at 4 years and 4 months post primary for hip instability (sub luxation).All devices revised successfully.
Additional Manufacturer Narrative
Correct device info received.The products involved in the complaints are not registered in usa, therefore no initial emdr should have been sent.

• Brand Name: CUP: VERSAFITCUP 01.26.2848MHC DOUBLE MOBILITY HC LINER Ø 48/28
• Common Device Name: HIP DOUBLE MOBILITY 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: 17361803
• Report Number: 3005180920-2023-00520
• Device Sequence Number: 6091323
• Product Code: MEH
• UDI-Device Identifier: 07630030807244
• UDI-Public: 07630030807244
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2023

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: 05/02/2023
• Device Model Number: 01.26.2848MHC
• Device Catalogue Number: 01.26.2848MHC
• Device Lot Number: 180667
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2018
• 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