MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT FLAT PE HC LINER Ø36/G

Catalog Number	01.32.3652HCT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 27 march 2018.Lot 166668: (b)(4) items manufactured and released on 13 december 2016 expiration date: 2021-11-24.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.Mpact acetabular shell ø60 two-holes reference (b)(4), lot 167728: (b)(4) items manufactured and released on 13 march 2017 expiration date: 2022-03-02 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.
Event or Problem Description
When the surgeon was implanting the liner, it wouldn't seat.The surgeon used a secondary liner (same reference, but different lot [174526]) to complete the surgery.The surgery was completed successfully.Five minutes of delay.
Additional Manufacturer Narrative
Visual inspection performed on 28 march 2018 by r&d product manager: the liner were checked: some holes were noticed in the liner, probably performed with bone screws to extract the liner.No particular other signs were noticed but a furher analysis from quality control was required.Investigation performed on 24 april 2018 by quality control manager: on apr 24, 2018 the cq responsible provided the results of the metrological analysis performed on the retrieved liner, reporting that the dimensional control had identified a slight deformation of the liner cone.Update performed by r&d product manager on 27 april 2018: the controls were performed and the dimension of the taper angle was slightly wider than the specifications: the value found was 0°0'33'' higher.The increased dimension can be related to the deformation occurred during its use, while the event is probably related to an impaction not properly in axis with the cup.

• Brand Name: MPACT FLAT PE HC LINER Ø36/G
• Common Device Name: FLAT PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7372846
• Report Number: 3005180920-2018-00184
• Device Sequence Number: 11119416
• Product Code: LPH
• UDI-Device Identifier: 07630030812156
• UDI-Public: 07630030812156
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 04/27/2018

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: 11/24/2021
• Device Catalogue Number: 01.32.3652HCT
• Device Lot Number: 166668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 04/27/2018
• 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: Other