MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 3; CEMENTLESS STEM

Model Number	01.18.413
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery at about 3 years and 3 months from primary for infection.All devices revised successfully.
Additional Manufacturer Narrative
Batch review performed on 12 january 2023: lot 1902240: (b)(4) items manufactured and released on 29-may-2019.Expiration date: 2024-05-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Additional items involved in the event, batch review performed on 12 january 2023: cup: versafitcup 01.26.45.0052 acetabular shell cc trio ø 52 (k103352) lot.1901418 lot 1901418: (b)(4) items manufactured and released on 19-jun-2019.Expiration date: 2024-06-05.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event in the period of review.Ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot.1901944 lot 1901944: (b)(4) items manufactured and released on 17-jun-2019.Expiration date: 2024-06-03.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event in the period of review.Liner: mectacer 01.29.413 ceramic liner ø 36 / e lot.1900819 (not registered in us) lot 1900819: (b)(4) items manufactured and released on 15-may-2019.Expiration date: 2024-05-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.
Additional Manufacturer Narrative
Second step surgery performed on (b)(6) 2023, confirmation of surgery received on 24 february 2023.New devices implanted successfully.
Event or Problem Description
Revision surgery at about 3 years and 3 months from primary for infection.All devices revised successfully and spacer implanted.

• Brand Name: STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 3
• Common Device Name: CEMENTLESS 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16332043
• Report Number: 3005180920-2023-00023
• Device Sequence Number: 6873427
• Product Code: LZO
• UDI-Device Identifier: 07630040720120
• UDI-Public: 07630040720120
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2023

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: 05/20/2024
• Device Model Number: 01.18.413
• Device Catalogue Number: 01.18.413
• Device Lot Number: 1902240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2019
• 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: 71 YR
• Patient Sex: Female