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

Model Number	01.12.23SN
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 march 2021.Lot 1903390: (b)(4) items manufactured and released on 27-aug-2019.Expiration date: 2024-08-17.No anomalies found related to the problem to date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by clinical affairs director: one year after primary cementless tha the patient feels pain and revision is performed.The stem is found only partially osseointegrated: removal is difficult.From the attached radiographs, pronounced areas of radiolucency can be seen since the immediate postoperative.The origin of these areas of low density cannot be determined, they may be resulting from difficulties encountered during preparation of the femoral canal, though there is no mention of such incident in the report.The root cause of this adverse event cannot be determined with the information at hand.
Event or Problem Description
From x-rays it was recognised insufficient osseointegration of the stem in the distal part, the patient had pain.The surgeon decided to revise the patient 1 year 2 months after the primary.During the surgery it was hard to remove the stem.
Additional Manufacturer Narrative
Visual inspection performed by medacta r&d department: during the analysis it is evaluated that a lot of residual of ha coating is present on the stem body, in particular almost whole proximal body is covered with ha.It is clear that the stem has not been correctly osseointegrated with the patient bone, and this should be the cause of the reported patient pain (stem movement).Looking at the stem neck and teaper a lot of scratches and signs, together with depp holes, are present, probably due to the difficult revision surgery.It is not possible to determine the root cause of the reported non-osseointegration.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11663062
• Report Number: 3005180920-2021-00285
• Device Sequence Number: 19578280
• Product Code: JDI
• UDI-Device Identifier: 07630030802638
• UDI-Public: 07630030802638
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 05/26/2021

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: 08/17/2024
• Device Model Number: 01.12.23SN
• Device Catalogue Number: 01.12.23SN
• Device Lot Number: 1903390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 65