MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø50 TWO-HOLES; HIP ACETABULAR SHELL

Catalog Number	01.32.150DH
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	04/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 may 2019: lot 176951: (b)(4).Expiration date: 2023-02-05.No anomalies found related to the problem.(b)(4).
Event or Problem Description
During the primary hip surgery, the 50mm 2-hole cup was found to be unstable after it was implanted.The surgeon removed the cup and upon further examination, a fracture was discovered in the superior acetabular wall.The surgeon re-implanted the cup and inserted a 6.5 x 30mm dome screw in the first hole.The surgeon determined that a 6.5 x 30mm dome screw could not be inserted into the second hole due to the fracture.The 50mm 2-hole cup and 6.5 x 30mm screw were then removed and a 52mm multi-hole cup and 3 dome screws were implanted as this allowed for more screw hole options.The 52mm cup was stable and the surgery was completed successfully.The reason for the breakage is probably the sizer that wouldn't fully seat and the surgeon hit the handle harder, which may have caused the crack.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø50 TWO-HOLES
• Common Device Name: HIP ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8619678
• Report Number: 3005180920-2019-00391
• Device Sequence Number: 11284441
• Product Code: LPH
• UDI-Device Identifier: 07630030810763
• UDI-Public: 07630030810763
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2019

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 Expiration Date: 02/05/2023
• Device Catalogue Number: 01.32.150DH
• Device Lot Number: 176951
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 05/17/2019
• 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