MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: CC E CC LIGHT 01.26.3244HCAT HOODED PE HC FIXED LINER Ø 32 / E; HIP HC LINER

Catalog Number	01.26.3244HCAT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 21 february 2019: lot 182640: (b)(4) items manufactured and released on 31-jul-2018.Expiration date: 2023-07-17.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 ((b)(4)), lot 183942: (b)(4) items manufactured and released on 13-sep-2018.Expiration date: 2023-09-02.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
During the surgery the surgeon tried three times to insert the liner in the cup without success.A new insert with different reference (ref (b)(4)) was used to complete successfully the surgery.

• Brand Name: LINER: CC E CC LIGHT 01.26.3244HCAT HOODED PE HC FIXED LINER Ø 32 / E
• Common Device Name: HIP HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8361563
• Report Number: 3005180920-2019-00086
• Device Sequence Number: 2370093
• 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): 02/22/2019

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: 07/17/2023
• Device Catalogue Number: 01.26.3244HCAT
• Device Lot Number: 182640
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 02/22/2019
• 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: 67 YR
• Patient Weight: 55