MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H COLLARED FEMORAL STEMS; AMISTEM COLLARED STEM COLLARED HA COATED LAT STEM SIZE 3

Model Number	01.18.243
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Implant Pain (4561); Radiolucent Lines (4848)
Date of Event	10/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 october 2024.Lot 170054: (b)(6) items manufactured and released on 20-apr-2017.Expiration date: 2022-04-03.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation: 6 years after primary cementless tha, a progressive loosening of the stem is reported and revision is undertaken.The stem looks slightly undersized from the postoperative image: the varus position probably misled the surgeon, but it is possible that good fixation was never achieved for lack of stability.No further comment can be offered with the information at hand.Conclusions: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
Revision surgery for pain and the surgeon noticed radiolucency around stem component.At about 6 years and 4 months post primary the surgeon revised all components and the surgery was completed successfully.

• Brand Name: AMISTEM H COLLARED FEMORAL STEMS
• Common Device Name: AMISTEM COLLARED STEM COLLARED HA COATED LAT STEM SIZE 3
• 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: 20786671
• Report Number: 3005180920-2024-00961
• Device Sequence Number: 15424525
• Product Code: LZO
• UDI-Device Identifier: 07630030804687
• UDI-Public: 07630030804687
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 11/26/2024

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: 04/03/2022
• Device Model Number: 01.18.243
• Device Lot Number: 170054
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2017
• 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: 75 YR
• Patient Sex: Male