MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-S CEMENTLESS, SAND BLASTED STD SIZE 1; HIP UNCEMENTED STEM

Model Number	01.12.001
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12-feb-2020: lot 147655: (b)(4) items manufactured and released on 16 february 2015.Expiration date: 31.12.2019 no anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Additional implants involved: batch review performed on 12-feb-2020: hip implant: ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot.17472.Lot 174720: (b)(4) items manufactured and released on 15 november 2017.Expiration date: 2022-11-06 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar reported event.Batch review performed on 28-feb-2020: hip implant: cup: versafitcup cc trio 01.26.45.1156 acetabular shell cc trio no-hole ø 56 (k122911) lot.174468.Lot 174468: (b)(4) items manufactured and released on 08-nov-2017.Expiration date: 25/10/2022.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.The shell liner involved in the complaint is not marketed in the usa.
Event or Problem Description
Revision surgery performed due to infection after about 2 years from the primary.

• Brand Name: STEM: QUADRA-S CEMENTLESS, SAND BLASTED STD SIZE 1
• Common Device Name: HIP UNCEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9768289
• Report Number: 3005180920-2020-00111
• Device Sequence Number: 16307040
• Product Code: JDI
• UDI-Device Identifier: 07630030801822
• UDI-Public: 07630030801822
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K072857
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: 01.12.001
• Device Catalogue Number: 01.12.001
• Device Lot Number: 147655
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 02/28/2020
• 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