MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA H CEMENTLESS FEMORAL STEM

Catalog Number	01.12.036
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	11/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2017 the medical affairs director made the following analysis: partial hip revision surgery occurred 4 years after primary tha in a (b)(6) man.Radiographic images provided show the presence of radiolucent lines around the stem suggesting implant mobilization.Aseptic loosening is a possible literature described adverse event after cementless total hip replacement and causes are often unknown.The reason of this event cannot be determined.Batch review performed on (b)(6) 2017 lot 114747: (b)(4) items manufactured and released on 01 mar 2012.Expiration date: 2017-01-31 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.
Event or Problem Description
Patient reported pain.The surgeon determined it looked loose.Performed revision surgery and found that the stem was loose.

• Brand Name: QUADRA H CEMENTLESS FEMORAL STEM
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7142938
• Report Number: 3005180920-2017-00765
• Device Sequence Number: 939198
• Product Code: JDI
• UDI-Device Identifier: 07630030802188
• UDI-Public: 07630030802188
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2017

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: 01/31/2017
• Device Catalogue Number: 01.12.036
• Device Lot Number: 114747
• 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: 11/22/2017
• Initial Report FDA Received Date: 12/22/2017
• 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: 81 YR
• Patient Weight: 93