MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 28 / B; HIP ACETABULAR LINER PE

Model Number	01.26.2837HCT
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 april 2022.Lot 185869: (b)(4) items manufactured and released on 25-sep-2018.Expiration date: 2023-08-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event.Additional component involved: ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 lot.2100260: (b)(4) items manufactured and released on 23-april-2021.Expiration date: 2026-04-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
At 3 days after the primary, the patient came in reporting pain due to a dislocation of the head from the liner and the cause is unknown.The surgeon revised the head and liner and the surgery was completed successfully.

• Brand Name: LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 28 / B
• Common Device Name: HIP ACETABULAR LINER PE
• 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: 14407315
• Report Number: 3005180920-2022-00373
• Device Sequence Number: 2478963
• Product Code: LZO
• UDI-Device Identifier: 07630030807053
• UDI-Public: 07630030807053
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K122911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2022

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: 08/30/2023
• Device Model Number: 01.26.2837HCT
• Device Catalogue Number: 01.26.2837HCT
• Device Lot Number: 185869
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2022
• Initial Report FDA Received Date: 05/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2018
• 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