MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-S CEMENTLESS, SAND BLASTED LAT STEM SIZE 5; CEMENTLESS SAND BLASTED STEM

Catalog Number	01.12.015
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 july 2018: lot 131246: (b)(4) items manufactured and released on 08 may 2013.Expiration date: 2018-03-31.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Ceramic head not marketed in u.S.The manufacturer of the ball head has been informed of the event, on july 17, 2018 they reported the component properties and the microstructure as obtained from the quality documents fulfil 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.
Event or Problem Description
About 2 years and 8 months after primary, the surgeon revised the patient hip for an infection.Head and stem swap.The surgery was completed successfully.

• Brand Name: QUADRA-S CEMENTLESS, SAND BLASTED LAT STEM SIZE 5
• Common Device Name: CEMENTLESS SAND BLASTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7726670
• Report Number: 3005180920-2018-00568
• Device Sequence Number: 1452295
• Product Code: JDI
• UDI-Device Identifier: 07630030801976
• UDI-Public: 07630030801976
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2018

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: 03/31/2018
• Device Catalogue Number: 01.12.015
• Device Lot Number: 131246
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2018
• Initial Report FDA Received Date: 07/27/2018
• 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 Age: 46 YR
• Patient Weight: 89