MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-C CEMENTED, MIRROR POLISHED STD STEM SIZE 3; CEMENTED HIP STEM

Catalog Number	01.12.43SN
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 february 2019: lot 171594: (b)(4) items manufactured and released on 09-may-2017.Expiration date: 2022-04-24.No anomalies found related to the problem.To date, (b)(4) items of this same lot have been already sold without any similar reported event.Other devices involved: versafitcup cc trio acetabular shell cc trio no-hole ø 50 reference 01.26.45.1150 (k122911).Lot 180113: (b)(4) items manufactured and released on 26-apr-2018.Expiration date: 2023-04-16.No anomalies found related to the problem.To date, (b)(4) items of this same lot have been already sold without any similar reported event.Liner cc e cc light flat pe hc liner ø 36/ e 01.26.3644hct (k120531).Lot 176658: (b)(4) items manufactured and released on 30-jan-2018.Expiration date: 2023-01-11.No anomalies found related to the problem.To date, (b)(4) items of this same lot have been already sold without any similar reported event.Cocr ball head 12/14 ø 36 size s -3.5 (k080885).Lot 157529: (b)(4) items manufactured and released on 01-mar-2016.Expiration date: 2021-02-16.No anomalies found related to the problem.To date, (b)(4) items of this same lot have been already sold with another similar reported event.Clinical evaluation performed by medical affairs manager on january 11, 2019.Early infection in cemented tha, 2 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
The patient was septic so the surgeon revised all implanted devices two months after primary surgery.

• Brand Name: QUADRA-C CEMENTED, MIRROR POLISHED STD STEM SIZE 3
• Common Device Name: CEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8310175
• Report Number: 3005180920-2019-00029
• Device Sequence Number: 1973417
• Product Code: LZO
• UDI-Device Identifier: 07630030802812
• UDI-Public: 07630030802812
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103189
• 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): 02/06/2019

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: 04/24/2022
• Device Catalogue Number: 01.12.43SN
• Device Lot Number: 171594
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 02/06/2019
• 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: 86 YR
• Patient Weight: 60