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

Model Number	01.12.032
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	03/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 march 2020: lot 132368: (b)(4) items manufactured and released on 06-aug-2013.Expiration date: 2018-06-30.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 since 2016.Clinical evaluation: mobilization of the femoral stem after 7 years in cementless primary tha, according to report subsequent to a traumatic event.The stem looks radiographically loose and upsizing was mandatory.No reason to suspect a malfunctioning device.Preliminary investigation: preliminary visual highlight signs of proximal osteointegration, but there is no image detail on the distal part.Implants covered in biological fluids.Liner with signs of extraction.Visual inspection: femoral stem with residual of ha layer on the very proximal part, femoral head and neck with scratches due to extraction.Burnishing on pe articulating surface and lipidic absorption colouration.
Event or Problem Description
Aseptic loosening of a quadra 6 years and 4 months after primary.Patient reported a fall in 2019.Quadra stem revised successfully with a bigger one.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 9932759
• Report Number: 3005180920-2020-00217
• Device Sequence Number: 14390695
• Product Code: JDI
• UDI-Device Identifier: 07630030802140
• UDI-Public: 07630030802140
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/07/2020

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: No Information
• Device Expiration Date: 06/30/2018
• Device Model Number: 01.12.032
• Device Catalogue Number: 01.12.032
• Device Lot Number: 132368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 04/07/2020
• 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: 58 YR
• Patient Weight: 76