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

Catalog Number	01.26.3239HCT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 september 2018; lot 180659: (b)(4) items manufactured and released on 28 may 2018.Expiration date: 2023-05-10; 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.Metrological analysis performed by quality control manager on 26 september 2018: from the documentation of lot, doesn't emerge anomalies; the whole dossier of manufacture is conforming to the specific project.The dimensional control, has not identified any anomaly or production defect.The device are conforming to the specifications of project.Visual inspection performed by r&d product manager on 26 september 2018; dimensional analysis requested.Dimensional analysis did not reveal any quote out of tolerance.It is not possible to determine a device related root cause.
Event or Problem Description
During the liner implantation the surgeon couldn't completely insert the inlay into the cup.Before impaction he checked that the cup was clean and free from any possible "disturbing" items (liquids, particles, tissues), anyway he couldn't insert the liner.The liner was then removed with a screw and he inserted another liner c, head 28.The surgery was then completed successfully.

• Brand Name: LINER: CC E CC LIGHT FLAT PE HC LINER Ø 32 / C
• Common Device Name: FLAT PE LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7909555
• Report Number: 3005180920-2018-00720
• Device Sequence Number: 11246904
• Product Code: LZO
• UDI-Device Identifier: 07630030807541
• UDI-Public: 07630030807541
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K120531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2018

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: 05/10/2023
• Device Catalogue Number: 01.26.3239HCT
• Device Lot Number: 180659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 09/26/2018
• 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