MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP FLAT PE HC LINER Ø 32 / E; FLAT PE LINER

Catalog Number	01.26.3244HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On an unknown date (after the primary surgery but prior to the revision one), the patient came in with a periprosthetic fracture and a long plate was implanted.After that, the patient came in for the infection.On (b)(6) 2017, the supplier of the ceramic ball head 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.Batch review performed on 04 september 2017.Lot 163172: (b)(4) items manufactured and released on 31 august 2016.Expiration date: 2021-08-18.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 05 september 2017 the medical affairs director performed a clinical evaluation and commented as follows: infection in cementless tha, 9 months after reoperation due to periprosthetic femoral fracture.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.
Event or Problem Description
The patient had an infection and the surgeon decided to take out the plate, change the mobile parts of the prosthesis (liner and head) and replace another plate.The surgeon revised the insert liner and replaced the ceramic head with a crco ball head.The surgery was completed successfully.

• Brand Name: VERSAFITCUP FLAT PE HC LINER Ø 32 / E
• Common Device Name: FLAT PE LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6844649
• Report Number: 3005180920-2017-00490
• Device Sequence Number: 1430174
• Product Code: LZO
• UDI-Device Identifier: 07630030807572
• UDI-Public: 07630030807572
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103352
• 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): 09/06/2017

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: 08/18/2021
• Device Catalogue Number: 01.26.3244HCT
• Device Lot Number: 163172
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2017
• Initial Report FDA Received Date: 09/06/2017
• 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: 78 YR
• Patient Weight: 90