MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H 01.12.032 CEMENTLESS, HA COATED LAT STEM SIZE 2; FEMORAL COMPONENT

Model Number	01.12.032
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 september 2021: lot 164553: (b)(4) items manufactured and released on 8-11-2016.Expiration date: 2021-10-17 no anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold without similar reported event since 2017.Visual inspection performed by r&d manager: looking at the images it is visible the explanted stem was covered with patient blood.It is not easy to identify if the ha coating has been absorbed completely by patient bone, even if it seems so.Some signs and scratches are present on the stem neck due to revision surgery.More details will be added during visual inspection if the stem will be available.The root cause remains unknown.
Event or Problem Description
Revision surgery was performed about 4 years after the primary surgery due to stem mobilization.The exact primary date is unknown.

• Brand Name: QUADRA-H 01.12.032 CEMENTLESS, HA COATED LAT STEM SIZE 2
• Common Device Name: FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12711292
• Report Number: 3005180920-2021-00828
• Device Sequence Number: 17389756
• Product Code: JDI
• UDI-Device Identifier: 07630030802140
• UDI-Public: 07630030802140
• 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 Explanted Year: 2021
• 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): 10/28/2021

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: 10/17/2021
• Device Model Number: 01.12.032
• Device Catalogue Number: 01.12.032
• Device Lot Number: 164553
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 10/28/2021
• 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: Other
• Patient Age: 59 YR