MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4; CEMENTLESS HA COATED STEM

Catalog Number	01.12.024
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on 27 november 2017: quadra-h cementless, ha coated std stem size 4 reference 01.12.024 (k082792): (b)(4).Acetabular shell cc trio no-hole ø 50 reference 01.26.45.1150 (k122911): (b)(4).Biolox delta ceramic ball head 12/14 ø 32 size m 0 reference 01.29.205 (k112115): (b)(4).Mectacer ceramic liner ø 32 / e reference 01.29.410 (device not marketed in us): (b)(4).Clinical evaluation performed by medical affairs director on 24 november 2017: infection in cementless primary tha 1,5 years after primary.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.Preliminary investigation based on the pictures received by the complainer performed by r and d hip manager on 19 december 2017: from the images no conclusion can be drawn.On all the implants some residual of both blood and bone can be noted.
Event or Problem Description
Patient was complaining of pain, tests were done to determine that the hip had a staphyloccocus infection.Surgeon decided to perform stage one revision and removed all of the current implants.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4
• Common Device Name: CEMENTLESS HA COATED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7129029
• Report Number: 3005180920-2017-00756
• Device Sequence Number: 11256505
• Product Code: JDI
• UDI-Device Identifier: 07630030802058
• UDI-Public: 07630030802058
• 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: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/19/2017

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: 11/07/2020
• Device Catalogue Number: 01.12.024
• Device Lot Number: 155091
• 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: 11/19/2017
• Initial Report FDA Received Date: 12/19/2017
• 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: 52 YR
• Patient Weight: 80