MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 3; CEMENTLESS STEM

Catalog Number	01.18.413
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31 january 2020: lot 182543: (b)(4) items manufactured and released on 18-sep-2018.Expiration date: 2023-09-04.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.Additional implants involved in the complaint, batch review performed on 31 january 2020.Cup: mpact 01.32.156dh acetabular shell 56 two-holes (k132879) lot.1901381 lot 1901381: (b)(4) items manufactured and released on 03-jun-2019.Expiration date: 2024-05-21.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.Screws: mpact 01.32.6530 cancellous bone screw, flat head 6,5 l 30 (k103721) lot.1904928 lot 1904928: (b)(4) items manufactured and released on 10-jul-2019.Expiration date: 2024-06-30.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.Screws: mpact 01.32.6525 cancellous bone screw, flat head 6,5 l 25 (k103721) lot.1904927 lot 1904927: (b)(4) items manufactured and released on 10-jul-2019.Expiration date: 2024-06-29.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: mpact 01.32.3648hct flat pe hc liner 36/f (k103721) lot.185988 lot 185988: (b)(4) items manufactured and released on 27-sep-2018.Expiration date: 2023-09-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.Ball heads: mectacer 01.29.210 biolox delta ceramic ball head 12/14 36 size l + 4 (k112115) lot.1901948 lot 1901948: (b)(4) items manufactured and released on 21-jun-2019.Expiration date: 2024-06-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.
Event or Problem Description
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 more than 2 months after primary.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 3
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9744696
• Report Number: 3005180920-2020-00089
• Device Sequence Number: 2456143
• Product Code: LZO
• UDI-Device Identifier: 07630040720120
• UDI-Public: 07630040720120
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 02/24/2020

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: 09/04/2023
• Device Catalogue Number: 01.18.413
• Device Lot Number: 182543
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 02/24/2020
• 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: 57 YR