MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT TRIAL SHELL Ø 48; SURGICAL INSTRUMENT FOR HIP

Catalog Number	01.32.10.0006
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	04/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The instrument and the related lot number are not available, so no analysis can be performed, not even a review of the batch documentation.
Event or Problem Description
During the primary hip surgery and after reaming the acetabulum to 47mm, the surgeon tapped the 48mm sizer with a mallet and the medial floor of the acetabulum fractured.The surgeon implanted a bone graft and a 48mm mpact multi-hole cup with screws.As the surgeon was impacting the liner, the cup moved.The surgeon then removed the 48mm cup and re-grafted and impacted the graft.The surgeon re-implanted the 48mm cup with screws and upon impacting the liner, the cup moved again.The surgeon decided to remove the 48mm mpact multi-hole cup and liner and implant another company's cup and liner.The surgery was completed successfully.The patient has osteopenia.

• Brand Name: MPACT TRIAL SHELL Ø 48
• Common Device Name: SURGICAL INSTRUMENT FOR HIP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8631621
• Report Number: 3005180920-2019-00395
• Device Sequence Number: 1654983
• Product Code: LXH
• UDI-Device Identifier: 07630040745635
• UDI-Public: 07630040745635
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2019

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 Catalogue Number: 01.32.10.0006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 05/22/2019
• 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