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

Catalog Number	01.32.3248HCT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: FLAT PE LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7421488
• Report Number: 3005180920-2018-00224
• Device Sequence Number: 10803074
• Product Code: LPH
• UDI-Device Identifier: 07630030811951
• UDI-Public: 07630030811951
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 04/11/2018
• 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: Other
• Patient Age: 51 YR