MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM C CEMENTED STD STEM SIZE 3; HIP CEMENTED STEM

Model Number	01.18.153
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2020: lot 156205:(b)(4) items manufactured and released on 11-jan-2016.Expiration date: 2020-12-13.No anomalies found related to the problem.To date, 58 items of the same lot have been already sold without any similar reported event since 1-1-2016.Clinical evaluation: hip revision surgery performed 4 years after hybrid total hip arthroplaty in a(b)(6) year old man.The former hybrid tha was already a revision of a former cementless stem.The bone was probably unfit to receive cement, because no interdigitation was achieved, particularly in gruen zones 1 to 3.Several variables can influence the cementation process such as temperature (of the implant and of the room), time of insertion, presence of liquids, conditions of the bone (in this case after previous stem removal), possible accidents during cement transportation or storage (e.G.Temporary temperature increase), and other possibilities not related to the implant.The reason of this event cannot be determined, but we see no hint towards a defective device.
Event or Problem Description
Revision surgery for stem loosening.Ceramic head, stem and liner revised successfully.The primary surgery was in 2016.

• Brand Name: STEM: AMISTEM C CEMENTED STD STEM SIZE 3
• Common Device Name: HIP CEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10634602
• Report Number: 3005180920-2020-00680
• Device Sequence Number: 16945154
• Product Code: LZO
• UDI-Device Identifier: 07630030804281
• UDI-Public: 07630030804281
• Combination Product (Y/N): Y
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• 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): 10/06/2020

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: 12/13/2020
• Device Model Number: 01.18.153
• Device Catalogue Number: 01.18.153
• Device Lot Number: 156205
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2020
• Initial Report FDA Received Date: 10/06/2020
• 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: 65 YR
• Patient Weight: 73