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

Catalog Number	01.32.3248HCT
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs on 16 february 2018: recurrent dislocation in primary cementless tha during the first few months.The one image supplied does not allow to evaluate fully the condition of the joint reconstruction.The stem is slightly in varus position, which is not a problem per se, but having only one hip represented we cannot estimate if lack of soft-tissue tension may have contributed, or perhaps a stem anteversion problem, possibly linked to anatomic peculiarities.No reason to suspect a faulty device for this adverse event.Batch review performed on 19 february 2018; lot 167597: (b)(4) items manufactured and released on 14 february 2017.Expiration date: 2022-01-31 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.Cocr ball head 12/14 ø 32 size s -3.5 reference 01.25.021 (k072857): lot 166594: (b)(4) items manufactured and released on 02 march 2017.Expiration date: 2022-02-16 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
On (b)(6) 2018 medacta sales representative was informed by the surgeon that a revision surgery will be necessary.Revision surgery performed on (b)(6) 2018 due to multiple luxation.Insert and head were revised.

• Brand Name: MPACT HCT FLAT PE HC LINER Ø32/F
• Common Device Name: FLAT PE LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7285369
• Report Number: 3005180920-2018-00073
• Device Sequence Number: 1772957
• Product Code: LPH
• UDI-Device Identifier: 07630030811951
• UDI-Public: 07630030811951
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 02/21/2018

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: 01/31/2022
• Device Catalogue Number: 01.32.3248HCT
• Device Lot Number: 167597
• 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: 01/22/2018
• Initial Report FDA Received Date: 02/21/2018
• 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: 65 YR
• Patient Weight: 74