MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-R CEMENTLESS, HA COATED REVISION STEM SIZE 1; CEMENTLESS FEMORAL STEM

Catalog Number	01.12.061
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 26 september 2017 the supplier of the ceramic ball head involved in this complaint (not marketed in us) provided a document review reporting as follows: the component properties and the microstructure as obtained from the quality document accomplish the requirements as specified at the time of production.There are no indications of any pre-existing material defect or non-conformities regarding sterilisation.Due to a lack of ceramic parts further investigations cannot be done.On 05 2017 the medical affairs director performed a clinical evaluation and commented as follows: early infection in tha, 3 months 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.Batch review performed on 12 october 2017.Lot 168430: (b)(4) items manufactured and released on 02 march 2017.Expiration date: 2022-02-21.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
Revision surgery due to infection.The surgeon replaced the medacta stem and other non-medacta components (cup, head and liner).The surgery was completed successfully.The pathogen won't be available.

• Brand Name: QUADRA-R CEMENTLESS, HA COATED REVISION STEM SIZE 1
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6944531
• Report Number: 3005180920-2017-00567
• Device Sequence Number: 1183508
• Product Code: LZO
• UDI-Device Identifier: 07630030802393
• UDI-Public: 07630030802393
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/12/2017

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: 02/21/2022
• Device Catalogue Number: 01.12.061
• Device Lot Number: 168430
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 10/12/2017
• 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: 56 YR
• Patient Weight: 91