MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H 01.12.023 CEMENTLESS, HA COATED STD STEM SIZE 3; HIP CEMENTLESS, HA COATED STD STEM

Model Number	01.12.023
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed 2 days after the primary surgery due to a periprosthetic fracture, for reasons unknown.Stem and head have been revised.Sales rep comment: the stem was undersized.A size 2 was planned, and then a size 3 has been implanted.But even a size 4 would have been undersized.
Additional Manufacturer Narrative
Batch review performed on 6 october 2022: lot 2111450: (b)(4) items manufactured and released on 24-jan-2022.Expiration date: 2027-jan-10.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.Visual inspection performed by r&d manager: during the analysis it is evaluated that all the ha coating is present on the stem body.Only one small part on the lateral stem is little bit scratched.This is expectable due the fact that the stem has been explanted after 2 days.Some signs and scratches are present on the neck surface probably due to revision surgery.We evaluated the shape and dimension of the stem comparing it with dedicated x-ray templates 100% scale and all parameters are in compliance to the specifications.It is not possible to determine the root cause of reported complaint.

• Brand Name: STEM: QUADRA-H 01.12.023 CEMENTLESS, HA COATED STD STEM SIZE 3
• Common Device Name: HIP CEMENTLESS, HA COATED STD 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15734901
• Report Number: 3005180920-2022-00810
• Device Sequence Number: 6316625
• Product Code: JDI
• UDI-Device Identifier: 07630030802041
• UDI-Public: 07630030802041
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 11/04/2022

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 Model Number: 01.12.023
• Device Catalogue Number: 01.12.023
• Device Lot Number: 2111450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2022
• 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: Female