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

Catalog Number	01.12.21SN
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 november 2023: lot 145915: (b)(4) items manufactured and released on 20-oct-2014.Expiration date: 2019-09-30.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Investigation performed by medacta r&d hip project manager: looking at the image attached to the complaint it is visible the stem covered with patient blood.It seems that whole the ha coating on the stem body has been completely absorbed by patient bone.Absorption of ha from the stem body can indicate that metabolic activity was taking place and that, presumably, adequate bone contact was achieved at the time of surgery.The post-op x-ray analysis could possibly provide more insight, such as the evaluation of possible early rotational instability or initial stress-shielding.The femoral head has been disconnected from the stem taper some signs and scratches are visible both on the stem body and on the head probably due to revision surgery.From the image attached it is not possible to add other hypotesis of the stem failure, the root cause remains unknown.
Event or Problem Description
At about 8 years and 11 months from the primary, the patient's x-rays showed thickening of the cortical walls at the distal part of the stem which is caused by the stem being loose.The surgeon removed the cocr head, the quadra-h stem and replaced it with a zimmer stem.Surgery completed successfully.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1, SHORT NECK
• Common Device Name: HIP CEMENTLESS 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: 18354766
• Report Number: 3005180920-2023-01003
• Device Sequence Number: 6923854
• 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: 2014
• 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): 12/19/2023

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: 09/30/2019
• Device Catalogue Number: 01.12.21SN
• Device Lot Number: 145915
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2014
• 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 Age: 59 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White