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

Model Number	01.18.136
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 february 2021 lot 135434: (b)(4) items manufactured and released on 02-july-2019.Expiration date: 2024-06-19.No anomalies found related to the problem to date, (b)(4) items of the same lot have been already sold without any other similar reported event clinical evaluation performed by medical affairs manager: stem and head revision performed 6 years and 5 months after primary cementless total hip arthroplasty in an elderly man ((b)(6) year old at time of revision surgery).In the radiographic image provided, radiolucent lines and signs of stress shielding are visible and the stem looks slightly undersized.The reason of this choice cannot be assessed on the basis of a single anteroposterior radiographic projection.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 surgery performed due to loosening 6 years 5 months after the primary.The surgeon revised the stem and the head.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM H HA COATED STD STEM SIZE 6
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11307402
• Report Number: 3005180920-2021-00095
• Device Sequence Number: 16987800
• Product Code: LZO
• UDI-Device Identifier: 07630030804120
• UDI-Public: 07630030804120
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2021

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: 06/19/2024
• Device Model Number: 01.18.136
• Device Catalogue Number: 01.18.136
• Device Lot Number: 135434
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 02/10/2021
• 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: 86 YR
• Patient Weight: 70