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

Catalog Number	01.26.3239HCT
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 jun 2024 lot 2348776: (b)(4) items manufactured and released on 29-jan-2024.Expiration date: 2029-01-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs department revision 1 month after the primary tha due to joint luxation between liner and head.From the radiographic image, no macroscopic malpositioning of the implants can be detected.It is therefore possible that insufficient soft tissue tension was achieved and therefore luxation was recurring.The chosen solution is a dm cup which provides additional stability.The original cup was not exchanged because of faulty performance due to the device.Additional revised implant.Batch review performed on 26 jun 2024 on ball heads: mectacer 01.25.022 cocr ball head 12/14 ø 32 size m 0 (k072857) lot.2336087 lot 2336087: (b)(4) items manufactured and released on 25-oct-2023.Expiration date: 2028-10-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
At about 1 month from the primary, revision surgery due to joint luxation between liner and head.Liner, head and cup revised and mpact dm successfully implanted.

• Brand Name: LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 32 / C
• Common Device Name: HIP LINER PE HC
• 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: 19749504
• Report Number: 3005180920-2024-00520
• Device Sequence Number: 6491413
• Product Code: LZO
• UDI-Device Identifier: 07630030807541
• UDI-Public: 07630030807541
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K120531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 07/16/2024

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 Catalogue Number: 01.26.3239HCT
• Device Lot Number: 2348776
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2024
• 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: Unknown