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

Catalog Number	01.32.148MB
Health Effect - Clinical Codes	Pain (1994); Joint Disorder (2373)
Date of Event	10/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 17 november 2017 the medical affairs performed a clinical evaluation and commented as follows: cup revision in cementless primary tha few months after primary operation.Early cup loosening is a rather rare occurrence.In this case, the one radiograph supplied does not show any significant indication: perhaps the cup is somewhat proud cranially from iliac bone and some muscle impingement may have contributed, but this should have been observed at revision and it is not apparent on the x-ray image.No final conclusion can be drawn.On 22 november 2017 the r&d project manager performed a preliminary investigation based on the available image and commented as follows: the image shows the cup and the dm liner explanted.The external surface of the cup had the coating with tissue and blood, apparently showing a good integration with the acetabulum but from the photo it is not possible to understand the root case of the event.Batch review performed on 20 november 2017.Lot 163814: (b)(4) items manufactured and released on 05 september 2016.Expiration date: 2021-08-28.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 complaining of pain.The surgeon thought the cup was loose.The surgeon revised the cup, head and liner.The surgery was completed successfully.

• Brand Name: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48
• Common Device Name: DOUBLE MOBILITY ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7057481
• Report Number: 3005180920-2017-00696
• Device Sequence Number: 117955
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/24/2017

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: 08/28/2021
• Device Catalogue Number: 01.32.148MB
• Device Lot Number: 163814
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 11/24/2017
• 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: Required Intervention
• Patient Age: 65 YR