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

Model Number	01.12.033
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 february 2020: lot 152983: (b)(4) items manufactured and released on 23-set-2015.Expiration date: 2020-09-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported since 2016.Clinical evaluation performed by medical affairs manager: delayed infection in cementless tha, 1 month 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.Additional items invovled in the event, batch review performed on 21 february 2020: cup: versafitcup cc trio 01.26.45.0052 acetabular shell cc trio ø 52 (k103352) lot.1903297.Lot 1903297: (b)(4) items manufactured and released on 05-july-2019.Expiration date: 2024-06-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported.Liner: cc e cc light 01.26.3644hct flat pe hc liner ø 36 / e (k103352) lot.1904384.Lot 1904384: (b)(4) items manufactured and released on 21-june-2019.Expiration date: 2024-06-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported.Ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 (k112115) lot.1903858.Lot 1903858: (b)(4) items manufactured and released on 24-july-2019.Expiration date: 2024-07-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported.
Event or Problem Description
Revision surgery performed 1 month after the primary due to an infection.The head, stem and inlay were revised and the pathogen kind is unknown.The stem was loose.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9822777
• Report Number: 3005180920-2020-00140
• Device Sequence Number: 3037115
• Product Code: JDI
• UDI-Device Identifier: 07630030802157
• UDI-Public: 07630030802157
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 03/12/2020

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: 09/07/2020
• Device Model Number: 01.12.033
• Device Catalogue Number: 01.12.033
• Device Lot Number: 152983
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 03/12/2020
• 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