MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48

Catalog Number	01.32.148MB
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 march 2018.Mpact double mobility acetabular shell ø48 reference 01.32.148mb; lot 173219: (b)(4) items manufactured and released on 4 august 2017.Expiration date: 2022-07-26.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.Double mobility hc liner 28/dmd reference 01.26.2848mhc (k092265); lot 166698:(b)(4) items manufactured and released on 17 january 2017.Expiration date: 2022-01-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with a similar reported event.Mectacer biolox delta ceramic ball head 12/14 ø 28 size s -3.5 reference 01.29.201 (k112115); lot 170680: (b)(4) items manufactured and released on 24 may 2017.Expiration date: 2022-05-14.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
The patient came in due to signs of infection.The pathogen is not available.The surgeon revised the head and liner.The surgery was completed successfully.

• Brand Name: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7365114
• Report Number: 3005180920-2018-00177
• Device Sequence Number: 1769233
• Product Code: LPH
• UDI-Device Identifier: 07630030860959
• UDI-Public: 07630030860959
• 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
• 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): 03/23/2018

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: 07/26/2022
• Device Catalogue Number: 01.32.148MB
• Device Lot Number: 173219
• 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: 02/22/2018
• Initial Report FDA Received Date: 03/23/2018
• 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