MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD STEM SIZE 4; HIP STEM CEMENTLESS

Catalog Number	01.18.134
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	12/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 9 years and 11 months after primary, the patient came in reporting pain due to a potted stem.The surgeon revised the stem and head with a competitor's product and revised the medacta liner with another medacta liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 15-dec-2023.Lot 132427: 70 items manufactured and released on 05-aug-2013.Expiration date: 2018-06-30.No anomalies found related to the problem.To date, 69 items of the same lot have been sold with one similar reported case during the period of review.Clinical evaluation performed by clinical affairs deparment revision 9 years and 11 months after primary tha due to a loosed stem.In the radiographic image provided, signs of stress shielding and radiolucent lines all around the stem are visible.The proximal femur looks significantly impoverished, probably as a consequence of the developing stress shielding.To better describe the evolution, the radiological history and lateral projections would be needed.In absense of different evidence, we assume this is a case of aseptic loosening which is a possible literature described adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason of this failure cannot be determined.

• Brand Name: STEM: AMISTEM H HA COATED STD STEM SIZE 4
• 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: 18465009
• Report Number: 3005180920-2023-01057
• Device Sequence Number: 3166907
• Product Code: LZO
• UDI-Device Identifier: 07630030804106
• UDI-Public: 07630030804106
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2023

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: 06/30/2018
• Device Catalogue Number: 01.18.134
• Device Lot Number: 132427
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2013
• 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: 65 YR
• Patient Sex: Male
• Patient Race: White