MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DMH

Catalog Number	01.26.2856MHC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 october 2019.Lot 1811183: 129 items manufactured and released on 12-feb-2019.Expiration date: 2024-01-28.No anomalies found related to the problem.To date, 84 items of the same lot have been already sold without any similar reported event.Another device involved in the event.Ball heads: cocr 01.25.012 cocr ball head 12/14 ø 28 size m 0 (k072857).Batch review performed on 22 october 2019.Lot 1810701: 120 items manufactured and released on 23-apr-2019.Expiration date: 2024-04-09.No anomalies found related to the problem.To date, 93 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in, 1 month after primary surgery, complaining of pain due to lack of healing on the wound site.The surgeon performed a washout and revised the medacta 28mm cocr head m with a medacta 28mm cocr head m and the medacta versafitcup dm liner hc 56/28 with a medacta versafitcup dm liner hc 56/28 due to suspect of infection.No deep infection confirmed during and after surgery.The surgery was completed successfully.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DMH
• Common Device Name: DOUBLE MOBILITY HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9289628
• Report Number: 3005180920-2019-00944
• Device Sequence Number: 13960807
• Product Code: MEH
• UDI-Device Identifier: 07630030807411
• UDI-Public: 07630030807411
• 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: 2019
• 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): 11/07/2019

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: 01/28/2024
• Device Catalogue Number: 01.26.2856MHC
• Device Lot Number: 1811183
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 11/07/2019
• 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