MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-C CEMENTED, MIRROR POLISHING STD STEM SIZE 1 12/14; HIP STEM

Catalog Number	01.12.041
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 august 2024: lot 2217313: (b)(4) items manufactured and released on 17-nov-2022.Expiration date: 2027-nov-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Analysis performed by r&d project manager: looking at the image attached to the complaint it is visible the explanted stem covered with patient blood.Also the explanted ceramic femoral head is visible in the image.From the image it is not possible to determine the root cause of explantation.Clinical evaluation performed by medical affairs director: a revision surgery was performed due to a periprosthetic infection, one and a half years after the primary total hip arthroplasty (tha).The available x-ray image reveals signs of loosening and bone alteration, particularly in the proximal femur.Infection is a known possible adverse event following any surgery, including tha.At this time, there is no reason to suspect that the cause is related to the implanted devices.Additional implants revised, batch review performed on 30 august 2024: ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot 2217239: (b)(4) items manufactured and released on 21-oct-2022.Expiration date: 2027-oct-04.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Cup: mpact 01.32.152dh acetabular shell ø52 two-holes (k132879) lot 2206762: (b)(4) items manufactured and released on 23-jun-2022.Expiration date: 2027-jun-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Liner: mpact 01.32.3644hct flat pe hc liner ø36/e (k103721) lot 2236947: (b)(4) items manufactured and released on 10-oct-2022.Expiration date: 2027-sep-27.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
Revision surgery performed about 1 year and 6 months after primary surgery due to infection.All components revised.

• Brand Name: STEM: QUADRA-C CEMENTED, MIRROR POLISHING STD STEM SIZE 1 12/14
• Common Device Name: HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 20299957
• Report Number: 3005180920-2024-00755
• Device Sequence Number: 8838366
• Product Code: LZO
• UDI-Device Identifier: 07630030802225
• UDI-Public: 07630030802225
• 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: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2024

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 Catalogue Number: 01.12.041
• Device Lot Number: 2217313
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown