MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT 3D METAL ACETABULAR SHELL Ø48 TWO-HOLE; HIP ACETABULAR CUP

Catalog Number	01.38.048DH
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At 3 months from the primary, the patient came in reporting pain due to a loose cup and unstable hip and the cause is unknown.The surgeon revised the head, cup, screws, and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 01 july 2024.Lot 2109317: (b)(4) items manufactured and released on 21-sept-2021.Expiration date: 2026-09-06.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.Additional components involved in the event: batch review performed on 01 july 2024.Liner: mpact 01.32.3239hct flat pe hc liner 32/c (k103721) lot 2108134: (b)(4) items manufactured and released on 03-aug-2021.Expiration date: 2026-07-19.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.Screws: mpact 01.43.0025 cancellous bone screw 6,5 l 25 (k200391) lot 2312899: (b)(4) items manufactured and released on 12-jul-2023.Expiration date: 2028-06-22.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.Ball heads: cocr 01.25.021 cocr ball head 12/14 32 size s -3.5 (k072857) lot 2306267: (b)(4) items manufactured and released on 01-jun-2023.Expiration date: 2028-05-14.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 3D METAL ACETABULAR SHELL Ø48 TWO-HOLE
• 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: 19806143
• Report Number: 3005180920-2024-00533
• Device Sequence Number: 7386665
• Product Code: LPH
• UDI-Device Identifier: 07630030812576
• UDI-Public: 07630030812576
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171966
• 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): 07/23/2024

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: 09/06/2026
• Device Catalogue Number: 01.38.048DH
• Device Lot Number: 2109317
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2021
• 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