MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3; HIP CEMENTLESS STEM

Catalog Number 01.12.033

Device Problem Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 11/15/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 15 november 2023 lot 124803: (b)(4) items manufactured and released on 17-jan-2013.Expiration date: 2017-12-31.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs department revision surgery at about 10 years 9 months after tha due to stem loosening.From the radiographic image signs of stress shielding and radiolucent lines in zone 1, zone 2, zone 6 and zone 7 are visible.Aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason of this failure cannot be determined.

Event Description

Revision surgery at about 10 years 9 months post-primary due to stem loosening.Patient had reported thigh pain.Quadra h removed and competitor cemented stem implanted.

Manufacturer Narrative

Device returned on 12 jan 2024.Visual inspection perfomed by r&d project manager: during the analysis it is evaluated that, looking at the stem body an opaque white film is visible on the proximal part of the stem.It is not possible to identify if this film is ha or bone residual, or a combined effect.Non-absorption of ha from the stem body can indicate that metabolic activity wasn't taking place and that, presumably, not adequate bone contact was achieved at the time of surgery.Some signs of huge damage and scratches are present on the neck of the explanted stem, which is likely due to the revision surgery and not relevant to the reported issue.Based on the analysis completed and information available, it is not possible to identify a root cause of the stem failure reported.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3
• Type of Device: 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: 18324592
• MDR Text Key: 330482803
• Report Number: 3005180920-2023-00953
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802157
• UDI-Public: 07630030802157
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 01.12.033
• Device Lot Number: 124803
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2013
• 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: 76 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White