MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø50

Catalog Number	01.32.150MB
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 march 2018: mpact double mobility acetabular shell ø50 reference: (b)(4) (k143453).Lot 175552: (b)(4) items manufactured and released on 13 december 2017; expiration date: 2022-12-05.No anomalies found related to the event.To date, (b)(4) items of the same lot have been already sold without any similar reported issue.Mpact dm double mobility hc liner 28/dme reference: (b)(4) (k092265) lot 174493: (b)(4) items manufactured and released on 14 november 2017; expiration date: 2022-10-30 no anomalies found related to the event.To date, (b)(4) items of the same lot have been already sold without any similar reported issue.Amistem h collared ha coated std stem size 0 reference (b)(4) (k121011) lot 171633: (b)(4) items manufactured and released on 4 august 2017; expiration date: 2022-07-24.No anomalies found related to the event.To date, (b)(4) items of the same lot have been already sold without any similar reported issue.Mectacer biolox delta ceramic ball head 12/14 ø 28 size l +3.5 reference (b)(4) (k112115) lot 172251: (b)(4) items manufactured and released on 27 july 2017; expiration date: 2022-07-18.No anomalies found related to the event.To date, (b)(4) items of the same lot have been already sold without any similar reported issue.
Event or Problem Description
The patient came in due to signs of infection.The surgeon revised all hardware.The surgery was completed successfully.

• Brand Name: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø50
• Common Device Name: DOUBLE MOBILITY ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7344706
• Report Number: 3005180920-2018-00156
• Device Sequence Number: 19028774
• Product Code: LPH
• UDI-Device Identifier: 07630030860966
• UDI-Public: 07630030860966
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2018

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: 05/12/2022
• Device Catalogue Number: 01.32.150MB
• Device Lot Number: 175552
• 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: 02/14/2018
• Initial Report FDA Received Date: 03/16/2018
• 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