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

Model Number	01.18.154
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05.Mar.2021: lot 148461: (b)(4) items manufactured and released on 23-feb-2015.Expiration date: 2020-01-31.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 since 2017.Additional items involved in the event, batch review performed on 05 march 2021: cup: versafitcup 01.26.48mb acetabular shell cc ø 48 (k083116) lot.187023.Lot 187023: (b)(4) items manufactured and released on 3-gen-2019.Expiration date: 2023-12-11.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.Liner: versafitcup dm 01.26.2848mhc double mobility hc liner 28/dmd (k092265) lot.1901454.Lot 1901454: (b)(4) items manufactured and released on 23-may-2019.Expiration date: 2024-05-12.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.Ball heads: mectacer 01.29.201 biolox delta ceramic ball head 12/14 ø 28 size s -3.5 (k112115) lot.1811825.Lot 1811825: (b)(4) items manufactured and released on 2-apr-2019.Expiration date: 2024-03-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar reported event.
Event or Problem Description
The patient came in 1 year and 7 months after the primary surgery due to signs of an infection and the pathogen is enterococcus.The surgeon performed a washout, removed all components and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM C CEMENTED STD STEM SIZE 4
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11561534
• Report Number: 3005180920-2021-00227
• Device Sequence Number: 4766674
• Product Code: LZO
• UDI-Device Identifier: 07630030804298
• UDI-Public: 07630030804298
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• 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): 03/24/2021

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: 01/31/2020
• Device Model Number: 01.18.154
• Device Catalogue Number: 01.18.154
• Device Lot Number: 148461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 03/24/2021
• 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