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

Catalog Number	01.32.158MB
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 march 2018; lot 164655: (b)(4) items manufactured and released on 21 october 2016.Expiration date: 2021-10-12 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.Mpact double mobility hc liner 28/dmi reference 01.26.2858mhc (k092265) lot 157126: (b)(4) items manufactured and released on 18 feb 2016.Expiration date: 2021-02-06 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.Mectacer biolox delta ceramic ball head 12/14 ø 28 size m 0 reference 01.29.202 (k112115) lot 167714: (b)(4) items manufactured and released on 07 mar 2017.Expiration date: 2022-02-16 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 investigation performed by ceramic ball head supplier on 19 february 2018 the component properties and the microstructure as obtained from the quality documents fullfil the requirements as specified at the time of production.There are no indications of any pre-existing material defect or non-conformities regarding sterilisation.Due to a lack of ceramic parts further investigations cannot be done.
Event or Problem Description
The patient came in complaining of dislocation.The cause of dislocation is unknown.The surgeon removed all medacta hardware and implanted another company's product.The surgery was completed successfully.

• 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: 7319698
• Report Number: 3005180920-2018-00121
• Device Sequence Number: 13480289
• Product Code: LPH
• UDI-Device Identifier: 07630030861000
• UDI-Public: 07630030861000
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2018

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: 10/12/2021
• Device Catalogue Number: 01.32.158MB
• Device Lot Number: 164655
• 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: 02/05/2018
• Initial Report FDA Received Date: 03/07/2018
• 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