MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES; HIP ACETABULAR CUP

Catalog Number	01.32.154DH
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Joint Impingement (4834)
Date of Event	08/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19-aug-2024.Lot 186946: (b)(4) items manufactured and released on 16-jan-2019.Expiration date: 2024-01-01.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.
Event or Problem Description
At about 5 years after primary, the patient came in reporting pain due to a cup impingement with the stem.The surgeon revised the head with medacta head an sleeve, and liner and cup with competitor's devices (the cup was at 13 degrees so he changed it to 20).Surgery was completed successfully.
Additional Manufacturer Narrative
During a random mdr check conducted on october 1, 2024, an error was noticed.A follow-up is being initiated to correct it.The k number (k132879) was erroneously inserted in the device bla field instead of in the pma/510(k).

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES
• 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: 20147355
• Report Number: 3005180920-2024-00711
• Device Sequence Number: 4275560
• Product Code: LPH
• UDI-Device Identifier: 07630030810824
• UDI-Public: 07630030810824
• 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: 2019
• 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,Followup
• Report Date (Section B): 10/09/2024

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 Expiration Date: 01/01/2024
• Device Catalogue Number: 01.32.154DH
• Device Lot Number: 186946
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2019
• 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 Sex: Unknown