MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; HIP ACETABULAR CUP

Model Number	01.32.154DH
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 june 2024.Lot 2244991: (b)(4) items manufactured and released on 22-feb-2023.Expiration date: 2028-02-06.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 9 months post primary during a ct scan control the surgeon noticed some points on the shell where the bone is not growing.No revision performed.
Additional Manufacturer Narrative
Additional devices invovled.Batch review performed on 30 september 2024.Ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot 2200870: (b)(4) items manufactured and released on 13-apr-2022.Expiration date: 2027-03-31.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.Liner: mpact 01.32.3644hct flat pe hc liner ø36/e (k103721) lot 2306406: (b)(4) items manufactured and released on 20-apr-2023.Expiration date: 2028-04-02.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.Updated device sales.Cup: mpact 01.32.154dh acetabular shell ø54 two-holes (k132879) lot 2244991: (b)(4) items manufactured and released on 22-feb-2023.Expiration date: 2028-02-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.

• Brand Name: MPACT ACETABULAR SYSTEM
• 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: 19566390
• Report Number: 3005180920-2024-00439
• Device Sequence Number: 7167808
• Product Code: LPH
• UDI-Device Identifier: 07630030810824
• UDI-Public: 07630030810824
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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: 02/06/2024
• Device Model Number: 01.32.154DH
• Device Catalogue Number: 01.32.154DH
• Device Lot Number: 2244991
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2023
• 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: Other
• Patient Sex: Unknown