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

Catalog Number	01.26.3239HCT
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 06 may 2019: lot 187915: (b)(4) items manufactured and released on 21-nov-2018.Expiration date: 2023-11-09.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 r&d (b)(4): it is not possible to check the dimensions of the liner because of the deformation occurred during the removal.A possible root cause could be that the liner was not positioned aligned with the shell; for this reason it was not possible to successfully insert the implant.
Event or Problem Description
The inlay did not fit into the cup.The surgeon tried a few times to impact it but it was not possible.Then he decided to use a new inlay of the same size, which fitted into the cup.

• Brand Name: LINER: CC E CC LIGHT FLAT PE HC LINER Ø 32 / C
• Common Device Name: KNEE PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8599634
• Report Number: 3005180920-2019-00358
• Device Sequence Number: 14038391
• Product Code: LZO
• UDI-Device Identifier: 07630030807541
• UDI-Public: 07630030807541
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/10/2019

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: 11/09/2023
• Device Catalogue Number: 01.26.3239HCT
• Device Lot Number: 187915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 05/10/2019
• 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