MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL Ø46 NO-HOLE; CEMENTLESS ACETABULAR SHELL

Catalog Number	01.32.146SH
Health Effect - Clinical Codes	Pain (1994); Joint Disorder (2373)
Date of Event	08/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on 25 september 2017.Lot 165744: (b)(4) items manufactured and released on 05 october 2016.Expiration date: 2021-09-26.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.Mpact flat pe hc liner ø28/b, code 01.32.2837hct, lot.165672 (k103721) (b)(4) items manufactured and released on 05 october 2016.Expiration date: 2021-09-20.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 determined the cup was loose.The cause of loosening is unknown.No report of trauma.The surgeon revised the cup, head and liner.The surgeon re-implanted with medacta product.The surgery was completed successfully.

• Brand Name: MPACT ACETABULAR SHELL Ø46 NO-HOLE
• Common Device Name: CEMENTLESS ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6893676
• Report Number: 3005180920-2017-00532
• Device Sequence Number: 99054
• Product Code: LPH
• UDI-Device Identifier: 07630030810725
• UDI-Public: 07630030810725
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• 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): 09/26/2017

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: 09/26/2021
• Device Catalogue Number: 01.32.146SH
• Device Lot Number: 165744
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2017
• Initial Report FDA Received Date: 09/26/2017
• 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