MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H COATED STD STEM SIZE 5; HIP UNCEMENTED STEM

Model Number	01.18.135
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 september 2020: lot 101313: (b)(4) items manufactured and released on 02-jul-2010.Expiration date: 2015-05-31.No anomalies found related to the problem.To date, 40 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medacta medical affairs director: hip revision surgery performed 9 years after cementless total hip arthroplasty in a (b)(6) man.Poor quality of the single radiographic image provided doesn't allow a proper clinical evaluation.The stem looks significantly subsided but no additional information can be retrieved from this image.Due to poor quality, a black sign in the lesser trochanter region could be mistaken for a bone fracture, but it must be an artifact as no mention of this was made in the report.Therefore, the reason of this event cannot be determined.
Event or Problem Description
Revision surgery performed, 9 years after primary surgery, due to stem loosening.Stem and head have been successfully replaced.

• Brand Name: AMISTEM H COATED STD STEM SIZE 5
• Common Device Name: HIP UNCEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10604873
• Report Number: 3005180920-2020-00678
• Device Sequence Number: 1281918
• Product Code: LZO
• UDI-Device Identifier: 07630030804113
• UDI-Public: 07630030804113
• 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: 2011
• Device Explanted Year: 2020
• 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): 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2015
• Device Model Number: 01.18.135
• Device Catalogue Number: 01.18.135
• Device Lot Number: 101313
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 09/30/2020
• 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: 71 YR
• Patient Weight: 88