MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA C CEMENTED STEM; CEMENTED FEMORAL STEM SIZE 0

Catalog Number	01.12.040
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 july 2017.Lot 091445: (b)(4) items manufactured and released on 18 july 2009.Expiration date: 2014-05-31.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.On 28th july 2017 the medical affairs made the following analysis: six years after primary hybrid tha in a very difficult case (probably after bone infection) the femoral bone gave way and the stem mobilized.A periosteal fracture is mentioned in the report.The adverse event has most probably a clinical origin but there no reason to suspect that it was due to a faulty device.
Event or Problem Description
Revision surgery about 6 years after primary due to periosteal fracture.The original quadra c stem was loose and was still subsiding due to a periosteal fracture.

• Brand Name: QUADRA C CEMENTED STEM
• Common Device Name: CEMENTED FEMORAL STEM SIZE 0
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6762726
• Report Number: 3005180920-2017-00426
• Device Sequence Number: 670325
• Product Code: LZO
• UDI-Device Identifier: 07630030802218
• UDI-Public: 07630030802218
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/03/2017

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: 05/31/2014
• Device Catalogue Number: 01.12.040
• Device Lot Number: 091445
• 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: 07/04/2017
• Initial Report FDA Received Date: 08/03/2017
• 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