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

Catalog Number	01.12.027
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection performed on 24.07.2018 by the responsible of packaging department, also the pictures received by the branch were analysed: the returned packaging was analysed and it is confirmed that the packaging is scratched and the tip of the stem is out of the white foam.This evidently occurred due to forces experienced during transportation, the carton box is damaged as well.This is indicated to be correlated to the combination of the packaging configuration applied and the possible involuntary hits experienced during shipping and transportation.Batch review performed on 27 july 2018.Lot 164548: (b)(4) items manufactured and released on 28 october 2016.Expiration date: 2021-10-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar reported event.
Event or Problem Description
The distal part of the stem went out of its foam.The stem was not used and it was replaced with a new one.

• Brand Name: QUADRA H CEMENTLESS STEM
• Common Device Name: FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7734724
• Report Number: 3005180920-2018-00591
• Device Sequence Number: 11424031
• Product Code: JDI
• UDI-Device Identifier: 07630030802089
• UDI-Public: 07630030802089
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/17/2021
• Device Catalogue Number: 01.12.027
• Device Lot Number: 164548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 07/31/2018
• 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: Other