MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P STD STEM SIZE 6; CEMENTLESS STEM

Catalog Number	01.18.406
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 july 2021.Lot 2010554: (b)(4) items manufactured and released on 21-jan-2021.Expiration date: 2026-01-12.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 item involved in the event, batch review performed on 05 july 2021 ball heads: mectacer 01.29.204 biolox delta ceramic ball head 12/14 ¿ 32 size s -4 ((b)(4) lot.2002596.Lot 2002596: 400 items manufactured and released on 15-july-2020.Expiration date: 2025-07-06.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
Hold for review (kp) the patient had a primary hip surgery on (b)(6) 2021.On (b)(6) 2021, the patient came in reporting pain due to a subsided stem.The cause of the subsided stem was unknown.The surgeon revised the stem and head and the surgery was completed successfully.Presently, on (b)(6) 2021, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the stem and head.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM P AMISTEM-P STD STEM SIZE 6
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12187272
• Report Number: 3005180920-2021-00605
• Device Sequence Number: 1322752
• Product Code: LZO
• UDI-Device Identifier: 07630040720052
• UDI-Public: 07630040720052
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/19/2021

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: 01/12/2026
• Device Catalogue Number: 01.18.406
• Device Lot Number: 2010554
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 07/19/2021
• 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