MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: CC E CC LIGHT HOODED PE HC FIXED LINER Ø 32 / E; HIP PE LINER

Catalog Number	01.26.3244HCAT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 14 december 2018; lot 183974: (b)(4) items manufactured and released on 26 june 2018.Expiration date: 2023-06-13.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 implant involved: cup: versafitcup cc trio 01.26.45.0050 acetabular shell cc trio ø 50 (k103352), lot 181695: (b)(4) items manufactured and released on 15 june 2018.Expiration date: 2023-06-06.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
It was not possible to couple the inlay with the cup.Another liner of the same size, but with a different lot was used to complete the surgery.

• Brand Name: LINER: CC E CC LIGHT HOODED PE HC FIXED LINER Ø 32 / E
• Common Device Name: HIP PE LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8164779
• Report Number: 3005180920-2018-01008
• Device Sequence Number: 2640500
• Product Code: LZO
• UDI-Device Identifier: 07630030807565
• UDI-Public: 07630030807565
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2018

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: 06/13/2023
• Device Catalogue Number: 01.26.3244HCAT
• Device Lot Number: 183974
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 12/14/2018
• 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: 70 YR
• Patient Weight: 80