MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM-P COLLARED STD STEM SIZE 2; HIP CEMENTLESS STEM

Catalog Number	01.18.432
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 18 june 2020: lot 1902246: (b)(4) items manufactured and released on 03-jun-2019.Expiration date: 2024-05-20.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.Other devices involved in the event: cup: mpact 01.32.148dh acetabular shell ø48 two-holes lot.(k132879).Batch review performed by medacta regulatory affairs department on 18 june 2020: lot 1901374: (b)(4) items manufactured and released on 17-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 without any similar reported event.Liner: mpact 01.32.3239hct flat pe hc liner ø32/c lot.186963 (k103721).Batch review performed by medacta regulatory affairs department on 18 june 2020: lot 186963: (b)(4) items manufactured and released on 16-oct-2018.Expiration date: 2023-10-02.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.Ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 lot.1901938 (k112115).Batch review performed by medacta regulatory affairs department on 18 june 2020: lot 1901938: (b)(4) items manufactured and released on 17-jun-2019.Expiration date: 2024-05-29.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 due to signs of infection 8 months after the primary surgery, the pathogen is unknown.The surgeon revised all implants and implanted an antibiotic spacer.

• Brand Name: STEM: AMISTEM-P COLLARED STD STEM SIZE 2
• 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: 10232816
• Report Number: 3005180920-2020-00404
• Device Sequence Number: 573298
• Product Code: LZO
• UDI-Device Identifier: 07630040720212
• UDI-Public: 07630040720212
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/06/2020

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: 05/20/2024
• Device Catalogue Number: 01.18.432
• Device Lot Number: 1902246
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2020
• Initial Report FDA Received Date: 07/06/2020
• 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