MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-C CEMENTED, MIRROR POLISHING STD STEM SIZE 0 12/14; HIP CEMENTED STEM

Catalog Number	01.12.040
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02-oct-2019.Lot 180193: 25 items manufactured and released on 18-apr-2018.Expiration date: 08.04.2023.No anomalies found related to the problem.To date, 21 items of the same lot have been already sold without any other similar reported event.Additional devices involved in the event: ball heads: cocr 01.25.032 cocr ball head 12/14 ø 36 size l +3.5 lot.155870 (k080885): batch review performed on 02-oct-2019.Lot 155870: 20 items manufactured and released on 11-jan-2016.Expiration date: 16.12.2020.No anomalies found related to the problem.To date, 18 items of the same lot have been already sold without any other similar reported event.Liner: impact 01.32.3652hcat hooded pe hc liner ø36/g lot.168491 (k132879): batch review performed on 02-oct-2019.Lot 168491: 60 items manufactured and released on 25-jan-2017.Expiration date: 15.01.2022.No anomalies found related to the problem.To date, 22 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2018.Subsequently, on (b)(6) 2018, the patient came in due to signs of infection and the pathogen was identified as streptococcus.The surgeon performed an i&d and revised the stem, head and liner.The surgery was completed successfully.Complaint 1839-18 was filed.On (b)(6) 2019, the patient came in due to signs of an infection.The surgeon performed an i&d and all implants were explanted and the surgeon implanted a head, stem, and liner with antibiotics.Presently, on (b)(6) 2019, the patient came in to have permanent hardware implanted.The surgeon removed the medacta head, stem, and liner that acted as a spacer and implanted permanent hardware.The surgery was completed successfully.

• Brand Name: STEM: QUADRA-C CEMENTED, MIRROR POLISHING STD STEM SIZE 0 12/14
• Common Device Name: HIP CEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9202083
• Report Number: 3005180920-2019-00882
• Device Sequence Number: 16245542
• Product Code: LZO
• UDI-Device Identifier: 07630030802218
• UDI-Public: 07630030802218
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2019

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: 04/08/2023
• Device Catalogue Number: 01.12.040
• Device Lot Number: 180193
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 10/17/2019
• 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: 56 YR