MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1; CEMENTLESS STEM

Model Number	01.12.021
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 march 2021: lot 186978: (b)(4) items manufactured and released on 11-dec-2018.Expiration date: 2023-11-28.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.
Event or Problem Description
Following stem loosening stem and inlay will be revised, the cup will be left in place.Revision surgery was planned for the (b)(6) 2021 but it was postponed due to coronavirus.Primary date is unknown.
Additional Manufacturer Narrative
The event description was corrected: following stem loosening it was planned to revised stem and inlay, the cup will be left in place.However, revision surgery was postponed and then not performed.The primary date is unknown.
Event or Problem Description
Following stem loosening it was planned to revised stem and inlay, the cup will be left in place.However, revision surgery was postponed and then not performed.The primary date is unknown.
Additional Manufacturer Narrative
The awareness date was corrected as march 23rd 2021.Batch review performed on 29 march 2021.Lot 186978: (b)(4) items manufactured and released on 11-dec-2018.Expiration date: 2023-11-28.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.
Event or Problem Description
Following stem loosening stem and inlay will be revised, the cup will be left in place.Revision surgery was planned for the (b)(6) 2021 but it was postponed due to coronavirus.Primary date is unknown.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11705226
• Report Number: 3005180920-2021-00315
• Device Sequence Number: 19587775
• Product Code: JDI
• UDI-Device Identifier: 07630030802027
• UDI-Public: 07630030802027
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2021

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: 11/28/2023
• Device Model Number: 01.12.021
• Device Catalogue Number: 01.12.021
• Device Lot Number: 186978
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 03/23/2021; 03/23/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 04/22/2021; 07/14/2021
• 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