MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-C CEMENTED, MIRROR POLISHING STEM SIZE 1 STD 12/14; CEMENTED FEMORAL STEM

Catalog Number	01.12.041
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	10/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2017.Lot 102748: 32 items manufactured and released on 13 september 2010.Expiration date: 2015-(b)(6).No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.On (b)(6) 2017 the medical affairs director performed a clinical evaluation and commented as follows: fracture of cement mantle in primary hybrid tha.The proximal femur is rather large in shape; a thick cement mantle was required to fit the stem in the large cavity and for unknown reasons the mantle broke off.This is not related to a defect in performance of the femoral stem.
Event or Problem Description
The patient reported thigh pain and upon x-ray investigation the surgeon diagnosed a loose cement mantle an stem loosening in the proximal third of the femur.Revision surgery was required, in which the stem was replaced after clearing of the cement mantle.It was confirmed that a substantial cement mantle fracture had occurred.
Additional Manufacturer Narrative
Analysis of the retrieved items performed by r&d project manager: no particular signs were noticed in the analysis of the pieces, only some scratches in the rim of the ceramic ball head, most probably occurred during the revision surgery.From the received parts it is not possible to determine the root cause of the event, but it ce be excluded that the event could be related to the performance of the device.

• Brand Name: QUADRA-C CEMENTED, MIRROR POLISHING STEM SIZE 1 STD 12/14
• Common Device Name: CEMENTED FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7040107
• Report Number: 3005180920-2017-00673
• Device Sequence Number: 1345401
• Product Code: JDI
• UDI-Device Identifier: 07630030802225
• UDI-Public: 07630030802225
• 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: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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: 08/31/2015
• Device Catalogue Number: 01.12.041
• Device Lot Number: 102748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/20/2017
• Supplement Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 11/17/2017
• Supplement 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 Weight: 60