MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P STD STEM SIZE 1; HIP STEM CEMENTLESS

Catalog Number	01.18.401
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	07/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 weeks from the primary, the patient came in reporting pain due to a loose stem and the cause of the loose stem is unknown.The surgeon revised the stem, head, and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 17-jul-2023 lot 2238563: (b)(4) manufactured and released on 11-jan-2023.Expiration date: 2027-12-19.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: STEM: AMISTEM P AMISTEM-P STD STEM SIZE 1
• Common Device Name: HIP STEM CEMENTLESS
• 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: 17424478
• Report Number: 3005180920-2023-00593
• Device Sequence Number: 5921669
• Product Code: LZO
• UDI-Device Identifier: 07630040720007
• UDI-Public: 07630040720007
• 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: 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): 07/31/2023

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: 01.18.401
• Device Lot Number: 2238563
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2023
• 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: Female