MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-C CEMENTED, MIRROR POLISHING STD STEM SIZE 4 12/14; CEMENTED HIP STEM

Model Number	01.12.044
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	06/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 june 2020 lot 182703: (b)(4) items manufactured and released on 18-jul-2018.Expiration date: 2023-07-03.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.Clinical evaluation performed by medical affairs director 1.5 years after primary hybrid tha the cement mantle subsided and detached from the bone, making the femoral construct unstable.The separation between cement and bone is clearly visible in the xrays supplied.No date is visible, so we can't tell if this happened secondarily or was a cement/cementation problem in the immediate postoperative.No reason to suspect a faulty device.
Event or Problem Description
Revision surgery performed due to stem subsidence 1 year and 6 months after primary.

• Brand Name: STEM: QUADRA-C CEMENTED, MIRROR POLISHING STD STEM SIZE 4 12/14
• Common Device Name: CEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10307068
• Report Number: 3005180920-2020-00433
• Device Sequence Number: 824920
• Product Code: LZO
• UDI-Device Identifier: 07630030802256
• UDI-Public: 07630030802256
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 07/22/2020

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: 07/03/2023
• Device Model Number: 01.12.044
• Device Catalogue Number: 01.12.044
• Device Lot Number: 182703
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 07/22/2020
• 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
• Patient Age: 65 YR