MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-P 01.12.122 QUADRA-P STD STEM SIZE 2; HIP QUADRA-P STD STEM

Catalog Number	01.12.122
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Unequal Limb Length (4534)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 march 2024 lot 2239147: (b)(4) items manufactured and released on 14-feb-2023.Expiration date: 2028-01-30.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.
Event or Problem Description
Revision due to a subsided stem and the cause is unknown.The patient was reporting a leg length discrepancy.At about 9 months post-primary the surgeon revised the head and the liner to give the patient more length.The stem was not removed because it was well-fixed.The surgery was completed successfully.

• Brand Name: STEM: QUADRA-P 01.12.122 QUADRA-P STD STEM SIZE 2
• Common Device Name: HIP QUADRA-P 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19040033
• Report Number: 3005180920-2024-00177
• Device Sequence Number: 17947806
• Product Code: LZO
• UDI-Device Identifier: 07630040720434
• UDI-Public: 07630040720434
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181254
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2024

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: 01.12.122
• Device Lot Number: 2239147
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2023
• 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 Age: 68 YR
• Patient Sex: Male
• Patient Weight: 89 KG