MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6; CEMENTLESS HIP STEM

Catalog Number	01.12.026
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Disorder (2373)
Date of Event	02/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director on 02 march 2018: late infection in cementless tha, 6.5 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.Batch review performed on 20 march 2018.(b)(4).Ceramic components (liner and head) are not marketed in us.Batch review performed by the manufacturer on 02 march 2018: no anomaly found.Pieces are in specification preliminary investigation performed by r and d product manager on 21 march 2018: from the analysis of the images provided, it is possible to state that revision was due to mobilization of the stem (probably due to infection).The stem and ceramic head components do not show any particular sign of damage.Ha layer looks completely absorbed during in-situ time.
Event or Problem Description
Surgeon notified on 20 february 2018 sales representative that he thought the stem looked loose.Surgeon performed revision surgery on (b)(6) 2018.During the case it became obvious there was a severe infection.The stem was able to be pulled out by hand quite easily.Surgeon then decided to revise the cup as well in order to do a full wash out.On 26 february 2018 sales representative reported: the surgeon confirmed that there was an infection.It is not possible say with 100 percent certainty it caused the loosening but it is most likely.The removal of cup definitely due to infection as it was a precaution due to the infection.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7360999
• Report Number: 3005180920-2018-00169
• Device Sequence Number: 128331
• Product Code: JDI
• UDI-Device Identifier: 07630030802072
• UDI-Public: 07630030802072
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2018

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: 05/31/2014
• Device Catalogue Number: 01.12.026
• Device Lot Number: 0912118
• 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: 02/20/2018
• Initial Report FDA Received Date: 03/22/2018
• 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: Required Intervention
• Patient Weight: 70