MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P COLLARED; HIP CEMENTLESS STEM

Model Number	01.18.432
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Implant Pain (4561)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 5 years 3 months after the primary, the patient came in reporting pain due to a loose stem and the cause is unknown.The surgeon revised the stem, head and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 28 october 2024.Lot 189969: (b)(4) items manufactured and released on 28-march-2019.Expiration date: 2024-03-18.No anomalies found related to the problem.To date, all items of the same lot have been sold with one similar reported events during the period of review.

• Brand Name: AMISTEM-P COLLARED
• 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: 20544241
• Report Number: 3005180920-2024-00902
• Device Sequence Number: 12730959
• Product Code: LPH
• UDI-Device Identifier: 07630040720212
• UDI-Public: 07630040720212
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2024

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 Expiration Date: 03/18/2024
• Device Model Number: 01.18.432
• Device Lot Number: 189969
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown