MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM P AMISTEM-P STD STEM SIZE 7; HIP STEM

Catalog Number	01.18.407
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 5 march 2024: lot 2300464: (b)(4) items manufactured and released on 20-apr-2023.Expiration date: 2028-apr-02.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.Additional implants involved, batch review performed on 5 march 2024: cup: versafitcup cc trio 01.26.45.0056 acetabular shell cc trio ø 56 (k103352) lot 2218992: (b)(4) items manufactured and released on 11-nov-2022.Expiration date: 2027-oct-30.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.Ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot 2311349: (b)(4) items manufactured and released on 07-jun-2023.Expiration date: 2028-may-15.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.Liner: mectacer 01.29.414 ceramic liner ø 36 / f (device not distributed in us) lot 2311363: (b)(4) items manufactured and released on 17-may-2023.Expiration date: 2028-may-01.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
Revision surgery performed about 5 months after the primary surgery due to infection.Revision completed successfully.

• Brand Name: AMISTEM P AMISTEM-P STD STEM SIZE 7
• Common Device Name: HIP STEM
• 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: 18966935
• Report Number: 3005180920-2024-00148
• Device Sequence Number: 6693983
• Product Code: LZO
• UDI-Device Identifier: 07630040720069
• UDI-Public: 07630040720069
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 03/25/2024

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: 01.18.407
• Device Lot Number: 2300464
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2023
• 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