MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3; CEMENTLESS HIP STEM

Model Number	01.12.023
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 january 2020: lot 147193: (b)(4) items manufactured and released on 13-feb-2015.Expiration date: 2019-12-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar event reported.Additional implant involved: ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 36 size m 0 (k112115) lot.148661.Batch review performed on 10 january 2020: lot 148661: (b)(4) items manufactured and released on 11-mar-2015.Expiration date: 2020-01-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar event reported.Additional implant involved: liner: mectacer 01.29.413 ceramic liner 36 / e lot.146042 (not distribute in the us) batch review performed on 15 january 2020: lot 146042: (b)(4) items manufactured and released on 14-jan-2015.Expiration date: 2019-10-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar event reported.Clinical evaluation performed by medical affairs director: early removal of femoral components in cementless tha because of infection.The components were not loose but the medical tram decided to remove the medical devices anyway.There is no indication that malfunctioning or defective devices may be responsible for the cause of reoperation.Visual inspection performed by r&d project manager from preliminary visual investigation, it is not possible to determine an implant related failure root cause.
Event or Problem Description
Revision surgery performed after 9 months from the last revision surgery due to an infection.The surgeon revised the stem and the head.During previous surgeries the surgeon performed only washouts due to an infection.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9652064
• Report Number: 3005180920-2020-00014
• Device Sequence Number: 1742227
• Product Code: JDI
• UDI-Device Identifier: 07630030802041
• UDI-Public: 07630030802041
• 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: 2015
• 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): 01/31/2020

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: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: 01.12.023
• Device Catalogue Number: 01.12.023
• Device Lot Number: 147193
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 01/31/2020
• 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: 63 YR
• Patient Weight: 90