MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM C CEMENTED STD STEM SIZE 2; CEMENTED HIP STEM

Model Number	01.18.152
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13.Apr.2021: lot 1901550: (b)(4) items manufactured and released on 7-jun-2019.Expiration date: 2024-05-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional implant involved: ball heads: bipolar head 25060.2845 bipolar head ø28x45 (k091967) lot.2006642.Batch review performed on 13.Apr.2021: lot 2006642: (b)(4) items manufactured and released on 16-sep-2020.Expiration date: 2025-08-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional implant involved: ball heads: cocr 01.25.011 cocr ball head 12/14 ø 28 size s -3.5 (k072857) lot.177463 batch review performed on 13.Apr.2021: lot 177463: (b)(4) items manufactured and released on 12-feb-2018.Expiration date: 2023-002-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
1 month after the primary surgery the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all implants and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM C CEMENTED STD STEM SIZE 2
• Common Device Name: CEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11731445
• Report Number: 3005180920-2021-00347
• Device Sequence Number: 3765690
• Product Code: LZO
• UDI-Device Identifier: 07630030804274
• UDI-Public: 07630030804274
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 04/27/2021

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: 05/25/2024
• Device Model Number: 01.18.152
• Device Catalogue Number: 01.18.152
• Device Lot Number: 1901550
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 04/27/2021
• 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