MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO HOODED PE HC FIXED LINER Ø 32 / E; HIP SHELL LINER

Model Number	01.26.3244HCAT
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 month post primary the patient was revised for hip infection.Liner and head revised successfully.The surgeon noticed some abrasion line in the liner and a yellow colouring of the polyethylene.
Additional Manufacturer Narrative
Batch review performed on 21 september 2022: lot 2114131: 110 items manufactured and released on 10-dec-2021.Expiration date: 2026-11-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event in the period of review.Additional device involved: batch review performed on 21 september 2022: mectacer 01.29.204 biolox delta ceramic ball head 12/14 ø 32 size s -4 (k112115) lot 2111080: 200 items manufactured and released on 06-dec-2021.Expiration date: 2026-11-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event in the period of review.Visual inspection performed by medacta r&d hip project manager on (b)(6) 2022: from the received part, it was possible to note a slight abrasion on the bottom of the inner surface od the poly liner.Morevover, a lipidic absorbment was noticed from the yellowed color of the liner.From the received information, the root cause is unknown, but it is subspected a third body presence.However, a cq analysis was required.Update of (b)(6) 2022.From the received controls, values were found in specifications, so the subspected abrasion was not present or, even if present for a third body presence, the liner was still in specifications.From the received information it is not possible to determine with certainty the root cause of the event, but we can exclude a failure of the device.

• Brand Name: VERSAFITCUP CC TRIO HOODED PE HC FIXED LINER Ø 32 / E
• Common Device Name: HIP SHELL 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15575573
• Report Number: 3005180920-2022-00770
• Device Sequence Number: 2780930
• Product Code: LZO
• UDI-Device Identifier: 07630030807565
• UDI-Public: 07630030807565
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K103352
• 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): 10/10/2022

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 Model Number: 01.26.3244HCAT
• Device Catalogue Number: 01.26.3244HCAT
• Device Lot Number: 2114131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2021
• 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