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

Model Number 01.12.021

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Inadequate Osseointegration (2646)

Event Date 03/23/2021

Event Type  Injury  

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 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.

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 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.

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 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.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1
• Type of Device: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11705226
• MDR Text Key: 246687273
• Report Number: 3005180920-2021-00315
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802027
• UDI-Public: 07630030802027
• Combination Product (y/n): N
• PMA/PMN Number: K082792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention