MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: CC E CC LIGHT FLAT PE HC LINER Ø 32 / C; HIP ACETABULAR LINER PE

Model Number	01.26.3239HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 2022.Lot 2107067: 90 items manufactured and released on (b)(6) 2021.Expiration date: 2026-07-05.No anomalies found related to the problem.To date, 71 items of the same lot have been already sold without any similar reported event.Additional component involved: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115) lot 2109337: 200 items manufactured and released on (b)(6) 2021.Expiration date: 2026-10-10.No anomalies found related to the problem.To date, 118 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The head and the liner were revised 19 days after primary due to a superficial infection.

• Brand Name: LINER: CC E CC LIGHT FLAT PE HC LINER Ø 32 / C
• 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: 14641193
• Report Number: 3005180920-2022-00431
• Device Sequence Number: 12205274
• Product Code: LZO
• UDI-Device Identifier: 07630030807541
• UDI-Public: 07630030807541
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120531
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2022

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: 07/05/2026
• Device Model Number: 01.26.3239HCT
• Device Catalogue Number: 01.26.3239HCT
• Device Lot Number: 2107067
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2021
• 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 Sex: Unknown