MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1; CEMENTLESS HIP STEM

Catalog Number	01.12.021
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 june 2018; lot 147634: (b)(4) items manufactured and released on 24 march 2015 expiration date: 2020-01-31 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs manager on 28 may 2018.Partial hip revision surgery occurred 2 years and 9 months after primary cementless total hip arthroplasty in a woman previously affected by polio.Radiographic images provided show the presence of radiolucent lines in gruen zones 1 and 7 suggesting proximal mobilization of the stem.Aseptic loosening of the stem is a possible literature described adverse event after cementless total hip arthroplasty and causes are often unknown: patient anatomy, bone morphology and comorbidities may represent risk factors for the long term survivorship of the implant.On the basis of available information, the reason of this failure cannot be determined.Preliminary investigation performed by r and d product manager on 20 june 2018.The images were analyzed; the stem appeared with coating partially absorbed, and some scratches were evident in its surface, especially in the intradox, probably occurred during the revision surgery.From the received images it can not be possible to determine the root cause of the event, but aseptic loosening of the stem is a possible literature described adverse event.
Event or Problem Description
Revision of the right stem 2 years and 9 months after primary.The primary stem had good distal fixation, however had moved proximally.The cortical bone in the metaphysis was thicker than usual.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7619809
• Report Number: 3005180920-2018-00438
• Device Sequence Number: 1623705
• Product Code: JDI
• UDI-Device Identifier: 07630030802027
• UDI-Public: 07630030802027
• 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: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/20/2018

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: 01/31/2020
• Device Catalogue Number: 01.12.021
• Device Lot Number: 147634
• 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: 05/21/2018
• Initial Report FDA Received Date: 06/20/2018
• 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: 72 YR
• Patient Weight: 60