MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H HA COATED LAT STEM SIZE 5; HIP CEMENTLESS STEM

Model Number	01.18.145
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	09/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26-sep-2022: lot 133084: (b)(4) items manufactured and released on 15-oct-2013.Expiration date: 2018-08-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medacta medical affairs manager: revision 8 years and 5 months of the femoral stem after primary tha due to stem loosening.No information concerning patient general health status and the presence of comorbidities is available.In the radiographic image provided, radiolucent lines and signs of stress shielding are visible.Aseptic loosening 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.Picture analysis: looking at the image attached to the complaint it seems that almost the ha coating on the stem body has been correctly aboserbed by patient bone.It is not possible to determine the root cause of reported stem loosening.
Event or Problem Description
At about 8 years and 5 months after the primary surgery, the patient came in reporting pain due to a loose stem and the cause of the loose stem is unknown.The surgeon revised successfully the medacta stem and head with competitor components.

• Brand Name: AMISTEM H HA COATED LAT STEM SIZE 5
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15604268
• Report Number: 3005180920-2022-00776
• Device Sequence Number: 2315138
• Product Code: LZO
• UDI-Device Identifier: 07630030804212
• UDI-Public: 07630030804212
• 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: 2022
• 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): 10/14/2022

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: 08/31/2018
• Device Model Number: 01.18.145
• Device Catalogue Number: 01.18.145
• Device Lot Number: 133084
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2013
• 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 Sex: Male