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

Model Number	01.12.023
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	12/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed at about 1 year and 10 months after the primary due to insufficient osseointegration of the proximal stem with intra-operative scar tissue that formed around the stem.Osteolysis was observed.The surgery was completed successfully revising stem and head.
Additional Manufacturer Narrative
Batch review performed on 27-dec-2022: lot 2006175: (b)(4) items manufactured and released on 22-oct-2020.Expiration date: 2025-10-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review additional device involved: batch review performed on 27-dec-2022: liner: cc e cc light 01.26.3648hct flat pe hc liner ø 36 / f (k103352) lot 2009643: (b)(4) items manufactured and released on 20-nov-2020.Expiration date: 2025-11-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review clinical evaluation performed by medacta medical affairs manager: revision 1 year and 10 months after the primary tha due to insufficient osteointegration of the proximal stem in a 79 year old male patient.Additionally, an intra-operative scar tissue formed around the stem was removed. radiographic images provided show a stem in varus position and possibly undersized.This could be the cause of the revision surgery but of course other evetns related to the post-operative period could have influenced the outcome.The revision surgery was completed successfully revising stem and head.Investigation perfomed by medacta r&d hip project manager: looking at the images attached to the complaint it is visible the stem covered with patient blood.On the body surfaces some residuals of ha coating are visible on the distal part of the stem and on the proximal part close to the resection line, meaning that the stem was not correctly osteointegrated with patient bone.On the neck part some signs and scratches are present probably due to revision surgery.It is not possible to determine the root cause of reported complaint.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3 L
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16136737
• Report Number: 3005180920-2022-00992
• Device Sequence Number: 17771383
• Product Code: JDI
• UDI-Device Identifier: 07630030802041
• UDI-Public: 07630030802041
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 01/11/2023

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: 10/13/2025
• Device Model Number: 01.12.023
• Device Catalogue Number: 01.12.023
• Device Lot Number: 2006175
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2020
• 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: 79 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White