MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 1; HIP CEMENTLESS STEM

Catalog Number	01.18.431
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 july 2020: lot 1905031: (b)(4) items manufactured and released on 12-sep-2019.Expiration date: 27-aug-2024.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.Other devices involved on the event: cup: mpact 01.32.150dh acetabular shell ø50 two-holes lot.1907398 (k132879).Batch review performed on 23 july 2020: lot 1907398: (b)(4) items manufactured and released on 04-dec-2019.Expiration date: 24-nov-2024.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 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 lot.1907346 (k112115).Batch review performed on 23 july 2020: lot 1907346: (b)(4) items manufactured and released on 21-jan-2020.Expiration date: 2025-01-08.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.Same patient, the same lot was used in the first revision surgery.Liner: mpact 01.32.3241hct flat pe hc liner ø32/d lot.1905497 (k103721).Batch review performed on 23 july 2020: lot 1905497: (b)(4) items manufactured and released on 03-jul-2019.Expiration date: 15-jun-2024.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.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2020.On 18 june 2020, the patient came in due to signs of infection and the pathogen was unknown.The surgeon performed a washout and revised the head and liner.The surgery was completed successfully.Presently, on (b)(6) 2020, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all components and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 1
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10349975
• Report Number: 3005180920-2020-00481
• Device Sequence Number: 3064959
• Product Code: LZO
• UDI-Device Identifier: 07630040720205
• UDI-Public: 07630040720205
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/31/2020

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: No Information
• Device Expiration Date: 08/27/2024
• Device Catalogue Number: 01.18.431
• Device Lot Number: 1905031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 07/31/2020
• 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: 53 YR