MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø58

Catalog Number	01.32.158MB
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 18 august 2017.Lot 165910: (b)(4) items manufactured and released on 18 january 2017.Expiration date: 2022-02-08.No anomalies found related to the problem.To date, this is the first item sold of this lot.
Event or Problem Description
During surgery the surgeon tried to implant a 58 dm cup, the cup would not seat properly.The surgeon used a 2-hole cup with screws.The surgeon had difficulty implanting the 2-hole cup.When the surgeon went to implant a size 3 standard femur, he was unable to stabilize the leg.At this time the surgeon was using a flat liner.The surgeon moved to a lateralized stem and a hooded liner to complete the surgery.The surgery was completed successfully.The surgeon stated he couldn't get a good press fit with the cup.The stem was switched for stability purposes.X-rays and explants are not available.

• Brand Name: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø58
• Common Device Name: DOUBLE MOBILITY ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6803634
• Report Number: 3005180920-2017-00460
• Device Sequence Number: 969014
• Product Code: LPH
• UDI-Device Identifier: 07630030861000
• UDI-Public: 07630030861000
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K143453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2022
• Device Catalogue Number: 01.32.158MB
• Device Lot Number: 165910
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2017
• Initial Report FDA Received Date: 08/18/2017
• 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: Other
• Patient Age: 35 YR