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

Model Number	01.18.153
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15.February.2021: lot 2002911: (b)(4) items manufactured and released on 10-aug-2020.Expiration date: 2025-07-05.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: cup: mpact 01.32.152mb double mobility acetabular shell ø52 (k143453) lot.2000204.Batch review performed on 15.February.2021: lot 2000204: (b)(4) items manufactured and released on 1-jul-2020.Expiration date: 2025-06-23.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: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot.165965 batch review performed on 15.February.2021: lot 165965: (b)(4) items manufactured and released on 10-jan-2017.Expiration date: 2021-12-19.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.Additional implant involved: liner: versafitcup dm 01.26.2852mhc double mobility hc liner 28/dmf (k092265) lot.2001457.Batch review performed on 15.February.2021: lot 2001457: (b)(4) items manufactured and released on 23-jun-2020.Expiration date: 2025-06-02.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 month after the primary surgery due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised all components.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM C CEMENTED STD STEM SIZE 3
• Common Device Name: CEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11337496
• Report Number: 3005180920-2021-00118
• Device Sequence Number: 3483735
• Product Code: LZO
• UDI-Device Identifier: 07630030804281
• UDI-Public: 07630030804281
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2021

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: 07/05/2025
• Device Model Number: 01.18.153
• Device Catalogue Number: 01.18.153
• Device Lot Number: 2002911
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 02/17/2021
• 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