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

Device Problem Migration (4003)

Patient Problem Unequal Limb Length (4534)

Event Date 03/07/2024

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 339328049
• Report Number: 3005180920-2024-00177
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630040720434
• UDI-Public: 07630040720434
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 01.12.122
• Device Lot Number: 2239147
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 89 KG