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

Model Number	01.18.413
Medical Device Problem Codes	Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	11/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was reporting pain.From the xrays, an empty space between the proximal edge of the prosthesis and the bone was noted (stem was not mobilized).The stem was revised about 1 year and 1 month after the primary surgery.
Additional Manufacturer Narrative
Batch review performed on 28 november 2022.Lot 2009288: (b)(4).Expiration date: 2025-nov-16.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 Manufacturer Narrative
Event desription has been updated given that the stem was confirmed as mobilized.
Event or Problem Description
The patient was reporting pain.From the xrays, an empty space between the proximal edge of the prosthesis and the bone was noted.The stem was mobilized.The stem was revised about 1 year and 1 month after the primary surgery.

• Brand Name: STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 3
• Common Device Name: HIP 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: 15996275
• Report Number: 3005180920-2022-00936
• Device Sequence Number: 17551813
• 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: 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,Followup
• Report Date (Section B): 01/05/2023

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: 11/16/2025
• Device Model Number: 01.18.413
• Device Catalogue Number: 01.18.413
• Device Lot Number: 2009288
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2022
• Supplement Date Received by Manufacturer: 11/25/2022
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2020
• 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: 54 YR
• Patient Sex: Male
• Patient Race: White