MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5; HIP UNCEMENTED STEM

Model Number	01.12.035
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14-jul-2020: lot 161560: (b)(4) items manufactured and released on 22-june-2016.Expiration date: 05-may-2021.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.Additional devices involved liner: versafitcup cc trio 01.26.3648hct flat pe hc liner 36 / f (k103352) lot 162312: (b)(4) items manufactured and released on 25-jul-2016.Expiration date: 23-jun-2021.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.The other revised components are not marketed in the usa.Preliminary investigation performed by medacta r&d hip manager: from the images received no conclusions can be achieved.We will wait to receive the devices in order to deeply analyse the event.
Event or Problem Description
Implant neck breakage, primary surgery performed on (b)(6) 2016.Revision surgery performed on (b)(6) 2020 (3 years and 6 months after primary).The patient had multiple revision surgeries due to infection, in 2017 and 2019.In those revisions surgeries, the head and the liner were replaced.
Additional Manufacturer Narrative
Visual inspection performed by medacta hip r&d manager: the femoral stem is fractured in 2 pieces in the neck portion: the proximal part is still connected to the ceramic femoral head, through a metallic sleeve.The ceramic femoral head has many scratches and gray signs probably due to the rubbing against metal surfaces, such as the fractured neck of the femoral stem.The proximal part of the neck has some scratches and 3 deeper indentations closed to the fracture.The fractured surface is not polished but rough.The distal portion of the distal part shows bone residual; on the fractured neck, many scratches, few burns and 2 deeper indentations are noted.The 2 indentations are closed to the fracture and corresponding to the position of the 3 indentations noted in the proximal part of the neck.These deep scratches (surface indentation) were present on the neck before the breakage occurred.The fractured surface is polished, ald also its edge, probably due to the rubbing against the ceramic head.The root cause of the event is likely the surface cracks that with time may lead to fracture of the involved region; the cracks are caused by some burns due to the electro-cutter or by some scratches due to the multiple revision surgeries.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5
• Common Device Name: HIP UNCEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10313460
• Report Number: 3005180920-2020-00449
• Device Sequence Number: 10968995
• Product Code: JDI
• UDI-Device Identifier: 07630030802171
• UDI-Public: 07630030802171
• 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: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/05/2021
• Device Model Number: 01.12.035
• Device Catalogue Number: 01.12.035
• Device Lot Number: 161560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 08/28/2020
• 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; Disability