MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA H FEMORAL STEMS; CEMENTLESS STEM

Catalog Number	01.12.23SN
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	02/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 february 2024.Lot 103961: (b)(4) items manufactured and released on 08-feb-2011.Expiration date: 2015-dec-31.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 surgery was performed about 12 years and 2 months after the primary surgery due to stem loosening.A femoral fracture was also noted but it is unknown when and how it happened.Fracture fixed and all implants revised to competitor system.
Additional Manufacturer Narrative
Clinical evaluation performed on (b)(6) 2024.Revision surgery about 12 years and 2 months after the tha surgery in a 73 year old female patient due to stem loosening.From the pre-op revision radiographic images radiolucent lines are visible.From the entity of the lines it appears that the stem mobilized.According to report, a femoral fracture was present but we are not able to see it from the available images.We could only see a cerclage and we assumed it was used to fix a fracture or to avoid fractures during the preparation of the femoral stem during index surgery but no info is given regarding this event.It may be possible that after all these years and the aging of the patient the bone structure has changed, which may have caused the loosening of the stem.During a random mdr check conducted on october 3, 2024, some errors were noticed.A follow-up is being initiated to correct them.Brand name (brand name aligned to gudid database has been entered in this follow-up).Clinical evaluation (it was not inserted in the initial report).K number (it was inserted in device bla field).

• Brand Name: QUADRA H FEMORAL STEMS
• Common Device Name: 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: 18951623
• Report Number: 3005180920-2024-00117
• Device Sequence Number: 17905035
• Product Code: JDI
• UDI-Device Identifier: 07630030802638
• UDI-Public: 07630030802638
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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 Expiration Date: 12/31/2015
• Device Catalogue Number: 01.12.23SN
• Device Lot Number: 103961
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2011
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 60 KG