MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 4; CEMENTLESS HIP STEM

Catalog Number	01.18.414
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Unspecified Infection (1930)
Date of Event	11/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 december 2020: lot 1907055: (b)(4) items manufactured and released on 11-dec-2019.Expiration date: 2024-12-01.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 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot.2000871.Batch review performed on 07 december 2020: lot 2000871: (b)(4) items manufactured and released on 24-jun-2020.Expiration date: 2025-06-03.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: mpact 01.32.3644hct flat pe hc liner ø36/e (k103721) lot.2006537.Batch review performed on 07 december2020: lot 2006537: (b)(4) items manufactured and released on 27-aug-2020.Expiration date: 2025-08-25.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 01.32.154mh acetabular shell ø54 multi-hole (k132879) lot.1811207.Batch review performed on 07 december 2020: lot 1811207: (b)(4) items manufactured and released on 08-apr-2019.Expiration date: 2024-03-26.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.
Event or Problem Description
The patient came in, 14 days after primary surgery, reporting pain due to a fractured acetabulum, and due to signs of an infection.The cause of the fracture is unknown, and the pathogen is unknown for the infection.The surgeon performed a washout for the infection and cabled and plated the fracture, and revised the liner, stem, cup, and head.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 4
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11053922
• Report Number: 3005180920-2020-00955
• Device Sequence Number: 2665645
• Product Code: LZO
• UDI-Device Identifier: 07630040720137
• UDI-Public: 07630040720137
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 12/22/2020

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: 12/01/2024
• Device Catalogue Number: 01.18.414
• Device Lot Number: 1907055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 12/22/2020
• 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