MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2, SHORT NECK; CEMENTLESS HIP STEM

Catalog Number	01.12.32SN
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	11/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 november 2017.Lot 141770: forty four (44) items manufactured and released on 30 april 2014.Expiration date: 2019-03-31.No anomalies found related to the problem.To date, 36 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed on (b)(6) 2017 by (b)(6): partial hip revision surgery (stem and head) occurred 3 years after primary cementless total hip arthroplasty.Radiographic images provided show the presence of radiolucent lines in gruen zones 1 and 7 and signs of stress shielding.Aseptic loosening is a possible, literature described adverse event after cementless total hip replacements and causes are often unknown.In this case the reason of failure cannot be determined.Preliminary investigation performed by r&d hip manager on (b)(6) 2017: from the images no conclusion can be drawn.On the stem surface residual of blood and bone can be noted.
Event or Problem Description
Three (3) years after primary the surgeon detected a stem proximal aseptic loosening with distal fixation.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2, SHORT NECK
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7121388
• Report Number: 3005180920-2017-00743
• Device Sequence Number: 11077782
• Product Code: JDI
• UDI-Device Identifier: 07630030802720
• UDI-Public: 07630030802720
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/15/2017

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: 03/31/2019
• Device Catalogue Number: 01.12.32SN
• Device Lot Number: 141770
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 12/15/2017
• 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: 50 YR
• Patient Weight: 108