MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM P STD STEM SIZE 8; HIP CEMENTLESS STEM

Catalog Number	01.18.408
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023: lot 2238585: 20 items manufactured and released on (b)(6) 2023.Expiration date: 2027-12-18.No anomalies found related to the problem.To date, 7 items of the same lot have been sold with no similar reported event during the period of review.Additional device involved: batch review performed on (b)(6) 2023.Masterloc 01.39.210 cementless ti coated lat stem size 10 (k151531) lot 2213489: 20 items manufactured and released on 24-oct-2022.Expiration date: 2027-10-12.No anomalies found related to the problem.To date, 14 items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation perfomred by medacta medical affairs manager: revision surgery on the same day of the primary due to femoral bone fracture on a overweight patient.After the primary, the surgeon decided to change the stem from amistem p size 6 to amistem-p size 8.A fracture was soon detected, the amistem-p was removed and it was implanted a masterloc with cerclage for the fracture as it is visible from the radiographic images.Unfortunately, 3 weeks after, the patient put weight on the operated leg and another fracture occured.The bone was weakened by the operation and due to the weight of the patient it fractured.A second revision was undertaken and m-vizion with cerclage was implanted.There is no reason to suspect a faulty device.
Event or Problem Description
Revision surgery performed on the same day of the primary due to femoral bone fracture.Amistem-p removed, fracture cabled and masterloc implanted.Three weeks after, the bone fractured again, probably because the patient fully load the joint a few days after surgery.M-vizion implanted successfully.

• Brand Name: AMISTEM P STD STEM SIZE 8
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17641503
• Report Number: 3005180920-2023-00653
• Device Sequence Number: 15349779
• Product Code: LZO
• UDI-Device Identifier: 07630040720076
• UDI-Public: 07630040720076
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 08/29/2023

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 Catalogue Number: 01.18.408
• Device Lot Number: 2238585
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2023
• 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 Age: 78 YR
• Patient Sex: Male
• Patient Weight: 112 KG