MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STEM SIZE 3 LAT; CEMENTLESS FEMORAL STEM

Catalog Number	01.12.033
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Joint Disorder (2373)
Date of Event	08/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2017 the medical affairs director performed a clinical evaluation and commented as follows: late infection in cementless tha, 6 years after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.On (b)(6) 2017 the r&d project manager performed a preliminary investigation based on the available picture and commented as follows: the image showed the implant after the removal from the patient; it is possible to notice some tissue and blood in the macrostructures, but from the received information it is not possible to connect the cause of the event to the implant.Batch reviews performed on (b)(6) 2017.Lot 092078: (b)(4) items manufactured and released on 29 october 2009.Expiration date: 2014-08-31.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.Versafitcup acetabular shell cc ø 54, code 01.26.54mbt, lot.100342 (not marketed in us) (b)(4) items manufactured and released on 08 april 2010.Expiration date: 2015-02-28.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 (b)(6) 2017, the supplier of the ceramic components involved in the complaint (not marketed in the us) provided a document review, reporting as follows: the component properties and microstructure as obtained from the quality documents accomplish the requirements as specified at the time of production.There are no indications of any pre-existing material defect or non-conformities regarding sterilization.Due to lack of ceramic parts, further investigations cannot be done.
Event or Problem Description
The patient presented to the surgeon with painful hip.Scan and hip aspirated revealed an infection.The revision surgery was completed through the harding approach and all components were removed.The femoral stem was loose with only small areas of bone on growth; the acetabular component was well fixed.An antibiotic impregnated spacer was implanted.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STEM SIZE 3 LAT
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6847605
• Report Number: 3005180920-2017-00494
• Device Sequence Number: 11143532
• Product Code: JDI
• UDI-Device Identifier: 07630030802157
• UDI-Public: 07630030802157
• 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: 2011
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/07/2017

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: 08/31/2014
• Device Catalogue Number: 01.12.033
• Device Lot Number: 092078
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 09/07/2017
• 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