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

Catalog Number	01.32.3244HCT
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 april 2019: lot 172557: (b)(4) items manufactured and released on 06-oct-2017.Expiration date: 2022-09-19.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.One other device was involved in the complaint ball heads: mectacer 01.29.206 biolox delta ceramic ball head 12/14 ø 32 size l +4 (k112115) lot.148659: (b)(4) items manufactured and released on 11-mar-2015.Expiration date: 2020-01-31.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
Revision surgery after 1 year and 2 months due to pain caused by a dislocation of the head from the liner (amis approach was used in the primary surgery).The cause of the dislocation is unknown.The surgeon revised the cup, liner and head.The surgery was completed successfully.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø32/E
• Common Device Name: HIP LINER FLAT PE HC
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8478396
• Report Number: 3005180920-2019-00245
• Device Sequence Number: 1019705
• Product Code: LPH
• UDI-Device Identifier: 07630030811913
• UDI-Public: 07630030811913
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2019

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: 09/19/2022
• Device Catalogue Number: 01.32.3244HCT
• Device Lot Number: 172557
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 04/03/2019
• 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: Required Intervention