MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H CEMENTLESS, HA COATED STD STEM SIZE 7; HIP UNCEMENTED STEM

Model Number	01.12.027
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 august 2020.Lot 180848: (b)(4) items manufactured and released on 22-may-2018.Expiration date: 2023-05-13.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 devices involved batch reviews performed on 31 july 2020.Cup: versafitcup cc trio 01.26.45.0062 acetabular shell cc trio 62 (k103352) lot 144699: (b)(4) items manufactured and released on 10-oct-2014.Expiration date: 2019-08-30.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 01.29.232h head biolox option 36 (k131518) lot 177731: (b)(4) items manufactured and released on 19-apr-2018.Expiration date: 2023-04-09.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 01.29.242a sleeve size l (k131518) lot 176863: (b)(4) items manufactured and released on 10-gen-2018.Expiration date: 2023-01-02.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.The explanted liner is not marketed in the usa.Clinical evaluation performed by medata medical affairs manager: delayed infection in cementless tha, 16 months after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.
Event or Problem Description
Revision surgery performed after 1 year and 4 months after primary surgery due to chronic infection.The surgeon revised all prosthesis.The revision was successfully completed via posterior approach and a cement spacer was inserted.The pathogen was streptococcus mitis.

• Brand Name: AMISTEM H CEMENTLESS, HA COATED STD STEM SIZE 7
• Common Device Name: HIP UNCEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10430567
• Report Number: 3005180920-2020-00525
• Device Sequence Number: 2344631
• Product Code: JDI
• UDI-Device Identifier: 07630030802089
• UDI-Public: 07630030802089
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082792
• 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): 08/20/2020

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: 05/13/2023
• Device Model Number: 01.12.027
• Device Catalogue Number: 01.12.027
• Device Lot Number: 180848
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 08/20/2020
• 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: 87 YR
• Patient Weight: 120