MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT SIZE 6; CEMENTLESS FEMORAL STEM

Model Number	01.18.146
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 may 2021: lot 173450: (b)(4) items manufactured and released on 13-nov-2017.Expiration date: 2022-10-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medacta medical affairs department: femoral component (stem, head and liner) revision performed 2 years and 4 months after primary cementless total hip arthroplasty in an elderly man ((b)(6) year old).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.
Event or Problem Description
Revision of femoral stem due to aseptic loosening 2 years and 4 months after primary surgery on an active patient that underwent osteotomies of the femur in the past due to dysplasia.The stem was found grossly loose and exchanged to quadra r.Liner was also exchanged to convertor and dual mobility as of surgeon preference for the revision case.

• Brand Name: STEM: AMISTEM H HA COATED LAT SIZE 6
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11907143
• Report Number: 3005180920-2021-00446
• Device Sequence Number: 1296734
• Product Code: LZO
• UDI-Device Identifier: 07630030804229
• UDI-Public: 07630030804229
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2021

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: 10/30/2022
• Device Model Number: 01.18.146
• Device Catalogue Number: 01.18.146
• Device Lot Number: 173450
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 05/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 65