MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL Ø50 MULTI-HOLE; CEMENTLESS ACETABULAR SHELL

Catalog Number	01.32.150MH
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch reviews performed on 21 july 2017.Lot 165282: (b)(4) items manufactured and released on 21 november 2016.Expiration date: 2021-11-09.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 cup impactor, code 01.32.10.0183, lot.1654383 (b)(4) items manufactured and released on 17 february 2017.No anomalies found related to the problem.To date, this is the second similar event reported on items of the same lot.
Event or Problem Description
During surgery the cup impactor would not disengage from the cup.The surgeon removed the impactor and cup.After 10 minutes, the surgeon was able to disengage the cup from the impactor.The surgeon manually impacted the cup with a ball impactor.The surgery was completed successfully.Instrumentation is available.
Additional Manufacturer Narrative
The cup was reported as available for investigation in the initial report, however the piece was never received by medacta international sa.The complaint has been closed without visual inspection of the item.In case of item return, a follow-up report will be sent to fda.On 29 september 2017 it was prepared a final report with the information already submitted in the initial report.On 06 october 2017 the report was sent to the initial reporter and the case was closed.

• Brand Name: MPACT ACETABULAR SHELL Ø50 MULTI-HOLE
• Common Device Name: CEMENTLESS ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6731724
• Report Number: 3005180920-2017-00396
• Device Sequence Number: 684975
• Product Code: LPH
• UDI-Device Identifier: 07630030810770
• UDI-Public: 07630030810770
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/09/2021
• Device Catalogue Number: 01.32.150MH
• Device Lot Number: 165282
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/22/2017
• Supplement Date Received by Manufacturer: 06/22/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 10/06/2017
• 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: Other
• Patient Age: 67 YR