MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 4; HIP CEMENTLESS STEM

Model Number	01.12.034
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 november 2020 lot 160817: 40 items manufactured and released on 26-apr-2016.Expiration date: 2021-04-14.No anomalies found related to the problem.To date, 39 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medacta medical affairs director 4 years after primary cementless total hip arthroplasty, radiographic image shows the presence of radiolucent lines.No information concerning patient general health status and the presence of comorbidities is available.Aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason of this event cannot be determined.
Event or Problem Description
Insufficient osteointegration of the stem.The surgeon revised successfully the stem 3 years and 11 months after primary surgery.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 4
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10821843
• Report Number: 3005180920-2020-00786
• Device Sequence Number: 2938237
• Product Code: JDI
• UDI-Device Identifier: 07630030802164
• UDI-Public: 07630030802164
• 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: 2016
• 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
• Report Date (Section B): 11/11/2020

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: 04/14/2021
• Device Model Number: 01.12.034
• Device Catalogue Number: 01.12.034
• Device Lot Number: 160817
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 11/11/2020
• 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: 63 YR