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	Unspecified Infection (1930)
Date of Event	01/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Infection after wound healing disorder.Head and liner revised 2 months after the primary surgery.
Additional Manufacturer Narrative
Batch review performed on 14 january 2022.Lot 2111760: (b)(4) items manufactured and released on 27-sep-2021.Expiration date: 2026-sep-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Clinical evaluation performed by medical affairs manager: delayed infection in cementless tha, few weeks after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.Additional item involved in the event, batch review performed on 14 january 2022: ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115) lot.2101454 lot 2101454: (b)(4) items manufactured and released on 28-may-2021.Expiration date: 2026-may-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.
Additional Manufacturer Narrative
Batch review performed on 14 january 2022.Lot 2111760: (b)(4) items manufactured and released on 27-sep-2021.Expiration date: 2026-sep-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Clinical evaluation performed by medical affairs manager: delayed infection in cementless tha, few weeks after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.Additional item involved in the event, batch review performed on 14 january 2022: ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115) lot.2101454 lot 2101454: (b)(4) items manufactured and released on 28-may-2021.Expiration date: 2026-may-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.
Event or Problem Description
Infection after wound healing disorder.Head and liner revised 2 months after the primary surgery.

• 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: 13469560
• Report Number: 3005180920-2022-00070
• Device Sequence Number: 14443857
• 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: 2021
• 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): 02/07/2022

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: 09/08/2026
• Device Model Number: 01.26.3244HCT
• Device Catalogue Number: 01.26.3244HCT
• Device Lot Number: 2111760
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2021
• 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: 78 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White