MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT FLAT PE HC LINER Ø32/F; FLAT PE LINER

Catalog Number	01.32.3248HCT
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	05/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 june 2018: lot 166660: (b)(4) items manufactured and released on 14 november 2018.Expiration date: 11-01-2021 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.Other device involved.Mectacer biolox delta ceramic ball head 12/14 ø 32 size xl +7 reference 01.29.207 (lot 163454: (b)(4) items manufactured and released on 04 october 2016.Expiration date: 2021-09-21 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
The patient came in complaining of pain and instability.The cause of pain and instability is unknown.The surgeon revised the head and liner.The surgery was completed successfully.Additional info received by medacta usa on the "4th july 2018": it is unknown if the instability caused the pain.No surgeon comment.

• Brand Name: MPACT FLAT PE HC LINER Ø32/F
• Common Device Name: FLAT PE LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7634078
• Report Number: 3005180920-2018-00458
• Device Sequence Number: 178657
• Product Code: LPH
• UDI-Device Identifier: 07630030811951
• UDI-Public: 07630030811951
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2018

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: 01/11/2021
• Device Catalogue Number: 01.32.3248HCT
• Device Lot Number: 166660
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 06/25/2018
• 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: 70 YR