MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H HA COATED LAT STEM SIZE 1; HIP CEMENTLESS STEM

Model Number	01.18.141
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	09/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 10 years after the primary, revision of the hip stem performed following the aseptical loosening of the stem.
Additional Manufacturer Narrative
Batch review performed on 13 october 2022: lot 102751: 56 items manufactured and released on 22-sept-2010.Expiration date: 2015-08-31.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medacta medical affairs manager: revision performed 10 years after tha in a female patient.No information concerning patient general health status and the presence of comorbidities is available.From the radiographic images provided, it is visible a macroscopic osteolitic reaction which may have been induced by polyethylene debris.A standard polyethylene insert had been chosen, possibly because of old age of the patient (age not specified).After 10 years of use, some patients may show a similar reaction to pe debris: it is not common but it has been shown in literature.This is also confirmed by a slightly eccentric position of the metallic femoral head.

• Brand Name: AMISTEM H HA COATED LAT STEM SIZE 1
• 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: 15604261
• Report Number: 3005180920-2022-00778
• Device Sequence Number: 2278610
• Product Code: LZO
• UDI-Device Identifier: 07630030804175
• UDI-Public: 07630030804175
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• 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): 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: 08/31/2015
• Device Model Number: 01.18.141
• Device Catalogue Number: 01.18.141
• Device Lot Number: 102751
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2010
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: White