MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5; HIP CEMENTLESS STEM

Model Number	01.12.025
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 march 2020: lot 180186: (b)(4) items manufactured and released on 30-may-2018.Expiration date: 2023-05-22.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 in the event: cup: mpact 01.32.156sh acetabular shell 56 no-hole lot.165753 (k132879) batch review performed on 09 march 2020: lot 165753: (b)(4) items manufactured and released on 28-nov-2016.Expiration date: 2021-11-15.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.Liner: mpact 01.32.3248hct flat pe hc liner 32/f (k103721) batch review performed on 09 march 2020: lot 180651: (b)(4) items manufactured and released on 25-apr-2018.Expiration date: 2023-04-15.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 01.29.206 biolox delta ceramic ball head 12/14 32 size l +4 (k112115) batch review performed on 09 march 2020 lot 177696: (b)(4) items manufactured and released on 16-mar-2018.Expiration date: 2023-03-01.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
Patient had original anterior hip replacement on (b)(6) 2018, no issues until 3 months ago, when he returned to dr with pain.After xray's and biopsy, infection was confirmed in femur.All implants removed 1 year and a half after primary for stage 1 revision.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5
• 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: 9909610
• Report Number: 3005180920-2020-00197
• Device Sequence Number: 14270878
• Product Code: JDI
• UDI-Device Identifier: 07630030802065
• UDI-Public: 07630030802065
• 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: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/01/2020

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: 05/22/2023
• Device Model Number: 01.12.025
• Device Catalogue Number: 01.12.025
• Device Lot Number: 180186
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 04/01/2020
• 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