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

Catalog Number	01.18.145
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 november 2019.Lot 177156: (b)(4) items manufactured and released on 12-mar-2018.Expiration date: 2023-02-27.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: hip revision performed 1 year after cementless total hip arthroplasty in a (b)(6) man.No information concerning patient age, general health status and the presence of comorbidities is available.In the radiographic image provided, radiolucent lines in the proximal gruen zones 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.
Event or Problem Description
Patient reported thigh pain at routine follow-up appointment, so he was sent for x-ray and loosening of the proximal stem was evident.The surgeon revised the stem almost 1 year after primary.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM HA COATED LAT STEM SIZE 5
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9479712
• Report Number: 3005180920-2019-01073
• Device Sequence Number: 4130440
• Product Code: LZO
• UDI-Device Identifier: 07630030804212
• UDI-Public: 07630030804212
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2019

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: 02/27/2023
• Device Catalogue Number: 01.18.145
• Device Lot Number: 177156
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 12/17/2019
• 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: 130