MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DOUBLE MOBILITY HC LINER 22.2/DMB

Catalog Number	01.26.2244MHC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 april 2018.Lot 155391: (b)(4) items manufactured and released on 11 january 2016.Expiration date: 2020-12-09.No anomalies found releated to the issue.To date, (b)(4) items of the same lot have been sold without any similar reported event.Amistem h reference 01.18.098 (k121011) ha coated std stem size 00; lot 122915a: (b)(4) items manufactured and released on 01 december 2017.Expiration date: 2022-11-21.No anomalies found releated to the issue.To date, only this item of the lot has been sold.Reference 01.25.123 (k080885) cocr ball head 12/14 ø 22 size m 0; lot 163199: (b)(4) items manufactured and released on 12 august 2016.Expiration date: 2021-07-19.No anomalies found releated to the issue.To date, (b)(4) items of the same lot have been sold without any similar reported event.Reference 01.32.144mb (k143453) double mobility acetabular shell ø44; lot 166633: (b)(4) items manufactured and released on 22 february 2017.Expiration date: 2022-02-12.No anomalies found releated to the issue.To date, (b)(4) items of the same lot have been sold without any similar reported event.Visual inspection performed by r&d product manager on 19 april 2018; the implant shows scratches on the neck and trunnion of the femoral stem and scratches on the edge and articulating surface of the acetabular cup.All of them were caused by extraction procedure.Clinical evaluation performed by medical affairs on 20 april 2018 early infection in cementless tha, 3 days after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.
Event or Problem Description
Three days after primary the surgeon revised the patient for a hip infection implanting a spacer made by: masterloc stem, cocr head, cementing mpact liner and using a competitor spacer for the acetabulum.On the (b)(6) 2018 the surgeon swapped the spaced with definitive implants.The surgery was completed successfully.

• Brand Name: MPACT DOUBLE MOBILITY HC LINER 22.2/DMB
• Common Device Name: DOUBLE MOBILITY HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7446814
• Report Number: 3005180920-2018-00254
• Device Sequence Number: 19320193
• Product Code: LZO
• UDI-Device Identifier: 07630030806803
• UDI-Public: 07630030806803
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K131458
• 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
• Report Date (Section B): 04/20/2018

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: 12/09/2020
• Device Catalogue Number: 01.26.2244MHC
• Device Lot Number: 155391
• 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: 03/22/2018
• Initial Report FDA Received Date: 04/20/2018
• 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