MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DM DOUBLE MOBILITY HC LINER Ø60/28; DOUBLE MOBILITY LINER

Catalog Number	01.26.2860MHC
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	01/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 february 2018: lot 160849: (b)(4) items manufactured and released on 31 may 2016.Expiration date: 2021-04-04.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Cocr ball head 12/14 ø 28 size m 0 reference 01.25.012 (k072857) lot 172861: (b)(4) items manufactured and released on 12 september 2017.Expiration date: 2022-08-30.No anomalies found related to the issue.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 due to signs of hematoma 10 days after surgery.The surgeon revised the head and liner.

• Brand Name: MPACT DM DOUBLE MOBILITY HC LINER Ø60/28
• Common Device Name: DOUBLE MOBILITY LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7292097
• Report Number: 3005180920-2018-00094
• Device Sequence Number: 1211657
• Product Code: MEH
• UDI-Device Identifier: 07630030807473
• UDI-Public: 07630030807473
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K092265
• 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): 02/23/2018

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: 04/04/2021
• Device Catalogue Number: 01.26.2860MHC
• Device Lot Number: 160849
• 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: 01/25/2018
• Initial Report FDA Received Date: 02/23/2018
• 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: 69 YR