MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT FLAT PE HC LINER Ø32/F; FLAT PE LINER

Catalog Number 01.32.3248HCT

Device Problems Residue After Decontamination (2325); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/13/2018

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 09 april 2018; lot 174332 : (b)(4) items manufactured and released on 30 november 2017.Expiration date: 2022-11-19; 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.Visual inspection performed by packaging and washing manager: the inlay has a residual of pe on the polar region.Probably, the event is due to an involuntary human error.The operator did not reject the inlay with the pe residual left after the turning activity.The instruction control expects a quality control of 100% of all implants verifying the homogeneity surface and the absence of material protrusions.

Event Description

The definitive liner was opened for implantation during surgery, it was notice before implantation there was an issue.The inlay has a residual of pe on the polar region.

• Brand Name: MPACT FLAT PE HC LINER Ø32/F
• Type of Device: FLAT PE LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7421488
• MDR Text Key: 105526817
• Report Number: 3005180920-2018-00224
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030811951
• UDI-Public: 07630030811951
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K103721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2022
• Device Catalogue Number: 01.32.3248HCT
• Device Lot Number: 174332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2018
• Date Device Manufactured: 11/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR