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

Catalog Number	01.26.3244HCT
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	10/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 november 2018.Lot 174337: (b)(4) items manufactured and released on 27 september 2017.Expiration date: 2022-09-05.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 revised: ball heads: cocr 01.25.023 cocr ball head 12/14 ø 32 size l +3.5, lot.166596:120 items manufactured and released on 09 march 2017.Expiration date: 2022-03-01.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
Patient returned to hospital with possible infection 9 months after primary surgery.Hip washout was performed and no infection detected.Bearing surfaces revised to provide new articulating surfaces.

• Brand Name: LINER: CC E CC LIGHT FLAT PE HC 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: 8064116
• Report Number: 3005180920-2018-00883
• Device Sequence Number: 2211001
• Product Code: LZO
• UDI-Device Identifier: 07630030807572
• UDI-Public: 07630030807572
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/05/2022
• Device Catalogue Number: 01.26.3244HCT
• Device Lot Number: 174337
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2018
• Initial Report FDA Received Date: 11/13/2018
• 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: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 90