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

Catalog Number	01.12.022
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); No Code Available (3191)
Date of Event	06/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 july 2018; lot 123113: (b)(4) items manufactured and released on 10 october 2012.Expiration date: 2017-08-31; no anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs (b)(4) on 06 july 2018: partial hip revision surgery occurred 5 years after primary cementless total hip arthroplasty in a (b)(6) year old woman.The radiographic images provided show the presence of radiolucent lines around the stem and signs of stress shielding suggesting implant mobilization.Immediate postoperative position cannot be assessed having only the immediate pre-revision x-ray.Also, we cannot judge if a slight undersizing of the stem may have played a role.However, lack of osseointegration, as described in the report, may also suggest that the cause for loosening could have been of biological reasons, and not only of mechanical origin.Aseptic loosening is a possible, literature described adverse event after cementless total hip arthroplasty and causes are often unknown.The reason of this failure cannot be determined.
Event or Problem Description
Revision due to stem aseptic loosening 4 years and 8 months after primary.Visible hypertophy of the bone surrounding the implant and lucent lines, as well as pain.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7666257
• Report Number: 3005180920-2018-00484
• Device Sequence Number: 19095262
• Product Code: JDI
• UDI-Device Identifier: 07630030802034
• UDI-Public: 07630030802034
• 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: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2018

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: 08/31/2017
• Device Catalogue Number: 01.12.022
• Device Lot Number: 123113
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 07/06/2018
• 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: 75 YR