MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM C CEMENTED STD STEM SIZE 4; CEMENTED HIP STEM

Model Number	01.18.154
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The exact patient weight has not been reported, the only information available is that it is less than 100 kg.Batch review performed on 26 march 2020: lot 1907518: (b)(4) items manufactured and released on 29-jan-2020.Expiration date: 2025-01-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional implant involved: ball heads: cocr 01.25.013 cocr ball head 12/14 ø 28 size l +3.5 (k072857) lot.1900775.Batch review performed on 26 march 2020: lot 1900775: (b)(4) items manufactured and released on 05-jun-2019.Expiration date: 2024-05-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional implant involved: liner: versafitcup dm 01.26.2854mhc double mobility hc liner ø 54/28 (k092265) lot.1903332.Batch review performed on 26 march 2020: lot 1903332: (b)(4) items manufactured and released on 24-jul-2019.Expiration date: 2025-07-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Preliminary investigation performed by r&d project manager.Implant covered in biological fluids.It is not possible to determine an implant related failure root cause.Clinical evaluation performed by medical affairs manager: early infection in hybrid tha, few weeks after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.
Event or Problem Description
1 month after primary surgery, revision surgery for infection.The stem, the head and the double mobile liner revised successfully.

• Brand Name: STEM: AMISTEM C CEMENTED STD STEM SIZE 4
• Common Device Name: CEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9961666
• Report Number: 3005180920-2020-00240
• Device Sequence Number: 16263640
• Product Code: LZO
• UDI-Device Identifier: 07630030804298
• UDI-Public: 07630030804298
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2020

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: 01/19/2025
• Device Model Number: 01.18.154
• Device Catalogue Number: 01.18.154
• Device Lot Number: 1907518
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 04/15/2020
• 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