MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: CC E CC LIGHT FLAT PE HC LINER Ø 28 / C; INSRERT FOR HIP SHELL

Catalog Number	01.26.2839HCT
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 09 july 2019: lot 172569: (b)(4) items manufactured and released on 28-jul-2017.Expiration date: 2022-07-16.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.Additional device involved in the complaint: batch review performed on 09 july 2019; batch review for cup: versafitcup cc trio 01.26.45.1148 acetabular shell cc trio no-hole ¿ 48 ((b)(4)) lot 188851: (b)(4) items manufactured and released on 12-feb-2019.Expiration date: 2024-01-29.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 medacta r&d hip project manager: from the metrological analysis of the liner, an unidentified abnormal deformation of the piece was noticed; we exclude an error occurred during production as the documental analysis on the batch do not report it.A possible cause of the deformation can be related to the sterilization of the piece in the hospital or an improper handling in the operating room during the impaction, for example an incorrect axial alignment with the cup during the impaction, but from the received data we cannot determine with certainty the root cause of the event.
Event or Problem Description
The liner doesn't enter in the cup, the surgery was completed using another implant.No delay reported.

• Brand Name: LINER: CC E CC LIGHT FLAT PE HC LINER Ø 28 / C
• Common Device Name: INSRERT FOR HIP SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8840206
• Report Number: 3005180920-2019-00630
• Device Sequence Number: 16203466
• Product Code: LZO
• UDI-Device Identifier: 07630030807091
• UDI-Public: 07630030807091
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103352
• 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): 07/30/2019

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: 07/16/2022
• Device Catalogue Number: 01.26.2839HCT
• Device Lot Number: 172569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 07/30/2019
• 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
• Patient Age: 81 YR
• Patient Weight: 65