MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø52 NO-HOLE; CEMENTLESS HIP SHELL

Catalog Number	01.32.152SH
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 december 2018: lot 165749: (b)(4) items manufactured and released on 24-november-2016.Expiration date: 2021-11-14.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
From the early post-op x-rays, the surgeon detected an acetabulum fracture.The patient will be non-weight bearing for 6 weeks.The surgeon plans to follow up on the fracture in 6 weeks to determine if it has healed properly.The surgeon does not feel that a revision will be necessary.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø52 NO-HOLE
• Common Device Name: CEMENTLESS HIP SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8155016
• Report Number: 3005180920-2018-00998
• Device Sequence Number: 16532190
• Product Code: LPH
• UDI-Device Identifier: 07630030810817
• UDI-Public: 07630030810817
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2018

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: 11/14/2021
• Device Catalogue Number: 01.32.152SH
• Device Lot Number: 165749
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 12/12/2018
• 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: Other