MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 8; CEMENTLESS HIP STEM

Model Number	01.12.028
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Osteolysis (2377)
Date of Event	11/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17-dec-2020: lot 136023: (b)(4) items manufactured and released on 12-mar-2014.Expiration date: 28-feb-2019.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.Additional implant involved: liner: cc e cc light 01.26.2844hct flat pe hc liner ø 28 / e (k103352) lot.140095.Batch review performed on 17-dec-2020: lot 140095: (b)(4) items manufactured and released on 10-feb-2014.Expiration date: 31-dec-2018.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.
Event or Problem Description
Revision surgery performed due to periprosthetic femur bone fracture, osteolysis was visible.The primary surgery was performed on (b)(6) 2014.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 8
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11053923
• Report Number: 3005180920-2020-00947
• Device Sequence Number: 11429286
• Product Code: JDI
• UDI-Device Identifier: 07630030802096
• UDI-Public: 07630030802096
• 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 Implanted Year: 2014
• 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): 12/22/2020

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: 02/28/2019
• Device Model Number: 01.12.028
• Device Catalogue Number: 01.12.028
• Device Lot Number: 136023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2020
• Initial Report FDA Received Date: 12/22/2020
• 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: 81 YR