MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA H FEMORAL STEM SIZE 4 STD; CEMENTLESS FEMORAL STEM

Catalog Number	01.12.024
Health Effect - Clinical Code	Fall (1848)
Date of Event	10/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 17 nov 2017 the medical affairs made the following analysis: hip revision surgery 11 years after primary total hip arthroplasty in a (b)(6) year old man.The single radiographic image provided shows signs of loosening around the stem.Aseptic loosening is a possible, literature described adverse event after cementless hip arthroplasty and reasons are often unknown.In this case, it is reported a traumatic event occurred during the first months after implantation that may have contributed.Micromovements in the early phase of bone remodelling and adhesion to the implant may compromise long term survival of the stem.However, the real cause of this failure cannot be determined.Batch review performed on 30 november 2017: lot 051857: (b)(4) items manufactured and released on 28 february 2006.Expiration date: 2010-12-31.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.
Event or Problem Description
Revision due to quadra-h aseptic loosening 11 years after primary.Patient had a fall in 2006 (primary surgery year) and the surgeon suspected it might be the reason for the loosening.The surgeon revised the ceramic head and the stem successfully.

• Brand Name: QUADRA H FEMORAL STEM SIZE 4 STD
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7070546
• Report Number: 3005180920-2017-00714
• Device Sequence Number: 1159226
• Product Code: JDI
• UDI-Device Identifier: 07630030802058
• UDI-Public: 07630030802058
• 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: 2006
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/30/2017

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: 12/31/2010
• Device Catalogue Number: 01.12.024
• Device Lot Number: 051857
• 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: 10/31/2017
• Initial Report FDA Received Date: 11/30/2017
• 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: 77 YR
• Patient Weight: 63