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

Model Number	01.18.144
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	07/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30.07.2021.Lot 160758: 44 items manufactured and released on 20-05-2016.Expiration date: 2021-05-03.No anomalies found related to the problem.To date, 31 items of the same lot have been sold without a similar reported event since 2017.Clinical evaluation performed by medacta medical affairs manager: hip revision surgery performed 4 years and 8 months after cementless total hip arthroplasty in a (b)(6) year old man.No information concerning patient general health status and presence of comorbidities is available however bone alterations of unknown origin, including also signs of stress shielding, are visible in the radiographic images provided.Aseptic loosening is a possible literature described mid-term adverse event and causes are often unknown.The reason of this event cannot be determined.Pictures evaluation performed by medacta r&d hip project manager: looking at the image attached to the complaint it is visible the expianted stem assembled with ceramic femoral head.Both the stem and the head are covered with patient blood.It is recognizable that the whole ha on the stem body has been completely absorbed by patient bone as expected.Some sings and scratches are present on the stem neck part and on the head, probably due to revision surgery it is not possible to determine the route cause of the reported stem loosening.
Event or Problem Description
Revision surgery was performed 4 years and 7 months after the primary surgery due to aseptic loosening of an amistem-h 4 lat.

• Brand Name: AMISTEM H COATED LAT STEM SIZE 4
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12370513
• Report Number: 3005180920-2021-00683
• Device Sequence Number: 3964713
• Product Code: LZO
• UDI-Device Identifier: 07630030804205
• UDI-Public: 07630030804205
• 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: 2016
• Device Explanted Year: 2021
• 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): 08/26/2021

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: 05/03/2021
• Device Model Number: 01.18.144
• Device Catalogue Number: 01.18.144
• Device Lot Number: 160758
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 08/26/2021
• 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 Age: 78 YR