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

Model Number	01.12.062
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15-jul-2020.Lot 124816: (b)(4) items manufactured and released on 24-jan-2013.Expiration date: 31-dec-2017.No anomalies found related to the problem to date, all items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs director: in order to carry out a proper analysis on this event, it is essential that good quality radiographs be available.A more detailed report on the findings at revision surgery is also recommended.From the technical point of view, analysis of the explants is essential.To date, no proper analysis can be made.
Event or Problem Description
Revision surgery performed due to breakage at the level of the mid-third of the stem body, 5 years and 6 months after from when the stem has been implanted.The broken quadra-r stem was implanted during a revision surgery on (b)(6) 2014, it was also implanted a competitor trochanteric plate.The trochanteric plate was recognized as broken on (b)(6) 2015, it has been revised on (b)(6) 2019.On (b)(6) 2020 the broken quadra-r stem has been revised.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: by looking at the x-rays of the broken quadra-r it is observed that the breakage is located at the mid-section of the stem body in correspondence with the original screw used for plate fixation.It is possible to assess that the screw contacted the stem shaft during the plate insertion or after the plate breakage.This may have damaged the shaft surface from which waves of fatigue fracture initiated.Looking at the fractured section we can easily see waves of fatigue fracture starting from the lateral frontal corner of the section, which is observed to be exactly the part of the stem contacted by the screw.In addition, some other signs of damage are also visible on the fractured stem shaft.
Event or Problem Description
Revision surgery performed due to breakage at the level of the mid-third of the stem body, 5 years and 6 months after from when the stem has been implanted.The broken quadra-r stem was implanted during a revision surgery on (b)(6) 2014, it was also implanted a competitor trochanteric plate.The trochanteric plate was recognized as broken on (b)(6) 2015, it has been revised on (b)(6) 2019.On (b)(6) 2020 the broken quadra-r stem has been revised.A downfall was reported in the medical history of the patient 2 weeks before the stem breakage.

• Brand Name: STEM: QUADRA -R CEMENTLESS, HA COATED REVISION STEM SIZE 2
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10354782
• Report Number: 3005180920-2020-00492
• Device Sequence Number: 11000600
• Product Code: JDI
• UDI-Device Identifier: 07630030802409
• UDI-Public: 07630030802409
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2020

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: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: 01.12.062
• Device Catalogue Number: 01.12.062
• Device Lot Number: 124816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 10/23/2020
• 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: 83 YR
• Patient Weight: 60