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

Model Number	01.12.025
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03-feb-2020: lot 162977: (b)(4) items manufactured and released on 02-aug-2016.Expiration date: 2021-07-21.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.Clinical evaluation performed by medacta medical affairs director: hip revision surgery performed 1 year and 10 months after cementless total hip arthroplasty in a (b)(6) years old man due to failure of secondary fixation.Reportedly, osseointegration never took place.No information concerning patient general health status, activity level and comorbidities is available.The partial image provided does not allow a proper clinical evaluation.The reason of this event cannot be determined.
Event or Problem Description
Revision surgery performed due to pain and not osseointegration of the stem after about 2 years from the primary surgery.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD 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: 9738112
• Report Number: 3005180920-2020-00075
• Device Sequence Number: 19286407
• Product Code: JDI
• UDI-Device Identifier: 07630030802065
• UDI-Public: 07630030802065
• 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: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2020

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: 07/21/2021
• Device Model Number: 01.12.025
• Device Catalogue Number: 01.12.025
• Device Lot Number: 162977
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 02/21/2020
• 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: 56 YR
• Patient Weight: 75