MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-P STD STEM SIZE 3; HIP STEM

Catalog Number	01.12.123
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Hip luxation occurred 1 day after the primary surgery.The stem was too much anteverted.All devices revised.
Additional Manufacturer Narrative
Clinical evaluation: a revision surgery for a tha was performed the day after the primary surgery due to a dislocation.The reported cause of the dislocation was excessive anteversion of the femoral stem.The available x-ray images confirm the hip dislocation and the position of the acetabular component slightly horizontal and cranially proud.We cannot evaluate the positioning of the stem due to image projection.Dislocation is a known complication following a tha, often resulting from malpositioning, as directly reported in this case.We have no reason to suspect a defective or malfunctioning device.Batch review performed on 17 june 2024: lot 2339733: 40 items manufactured and released on 23-jan-2024.Expiration date: 2029-01-03.No anomalies found related to the problem.To date, 15 items of the same lot have been sold with no similar reported event during the period of review.Additional components involved in the event: batch review performed on 17 june 2024 ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot.2407952: 100 items manufactured and released on 15-apr-2024.Expiration date: 2029-03-26.No anomalies found related to the problem.To date, 36 items of the same lot have been sold with no similar reported event during the period of review.Not registered in usa batch review performed on 17 june 2024 liner: mectacer 01.29.414 ceramic liner ø 36 / f lot 2310194: 90 items manufactured and released on 10-may-2023.Expiration date: 2028-04-15.No anomalies found related to the problem.To date, 89 items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: STEM: QUADRA-P STD STEM SIZE 3
• 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: 19667046
• Report Number: 3005180920-2024-00495
• Device Sequence Number: 20561415
• Product Code: LZO
• UDI-Device Identifier: 07630040720441
• UDI-Public: 07630040720441
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K181254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 07/03/2024

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: 01.12.123
• Device Lot Number: 2339733
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 46 YR
• Patient Sex: Male
• Patient Weight: 87 KG