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

Catalog Number	01.26.3244HCAT
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	04/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 may 2018.Lot 174477: 130 items manufactured and released on 15 september 2017.Expiration date: 2022-08-28.No anomalies found related to the problem.To date, 117 items of the same lot have been already sold without any similar reported event.Mectacer biolox delta ceramic ball head 12/14 ø 36 size s - 4 reference (b)(4).Lot 175436: 167 items manufactured and released on 22 november 2017.Expiration date: 2022-11-07 no a.Nomalies found related to the problem.To date, 149 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision due to irreducible left hip luxation 2 months after primary.Periarticular calcifications found.All the components were revised.Amis approach used in both primary and revision.
Additional Manufacturer Narrative
On 18 may 2018, the supplier of the ceramic head provided the requested review, with the following outcomes: the component properties and the microstructure as obtained from the quality documents accomplish the requirements as specified at the time of production.There are no indications of any pre-existing material defect due to a lack of ceramic parts further investigations cannot be done.

• Brand Name: LINER CC E CC LIGHT HOODED PE HC FIXED LINER Ø 32 / E
• Common Device Name: FIXED LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7514382
• Report Number: 3005180920-2018-00328
• Device Sequence Number: 1164594
• Product Code: LZO
• UDI-Device Identifier: 07630030807565
• UDI-Public: 07630030807565
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2018

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: 08/28/2022
• Device Catalogue Number: 01.26.3244HCAT
• Device Lot Number: 174477
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/16/2018
• Supplement Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 06/14/2018
• 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: Required Intervention
• Patient Age: 59 YR
• Patient Weight: 85