MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø52; HIP ACETABULAR CUP

Catalog Number	01.32.152MB
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery at 1 week from primary, shell, head and liner revised successfully.The patient luxated his hip and sustained a closed reduction, but after this, in the x-rays done in the er, it was noticed that the shell was out of the acetabulum bone.It is unknown if the luxation was due to the cup failure or if the cup failure was generated during the closed reduction.
Additional Manufacturer Narrative
Batch review performed on 3 july 2024: lot 2317983: (b)(4) items manufactured and released on 14-feb-2024.Expiration date: 2029-01-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional component involved in the event: batch review performed on 3 july 2024: liner: mpact dm 01.26.2852mhc double mobility hc liner 28/dmf (k092265) lot 2343972: (b)(4) items manufactured and released on 17-jan-2024.Expiration date: 2029-01-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø52
• Common Device Name: HIP ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19749121
• Report Number: 3005180920-2024-00548
• Device Sequence Number: 6513874
• Product Code: LPH
• UDI-Device Identifier: 07630030860973
• UDI-Public: 07630030860973
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2024

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: 01.32.152MB
• Device Lot Number: 2317983
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female