MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H 01.12.21SN CEMENTLESS, HA COATED STD STEM SIZE 1, SHORT NECK; HIP STEM

Model Number	01.12.21SN
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 march 2023: lot 146208: (b)(4) manufactured and released on 17-nov-2014.Expiration date: 2019-10-31.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event in the period of review.
Event or Problem Description
Revision surgery due to stem loosening.At about 7 years and 11 months from primary the surgeon swapped successfully the stem and head.

• Brand Name: STEM: QUADRA-H 01.12.21SN CEMENTLESS, HA COATED STD STEM SIZE 1, SHORT NECK
• 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: 16722678
• Report Number: 3005180920-2023-00233
• Device Sequence Number: 7293278
• Product Code: JDI
• UDI-Device Identifier: 07630030802614
• UDI-Public: 07630030802614
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• 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): 04/12/2023

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: 10/31/2019
• Device Model Number: 01.12.21SN
• Device Catalogue Number: 01.12.21SN
• Device Lot Number: 146208
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2014
• 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