MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT 3D METAL ACETABULAR SHELL Ø54 MULTI-HOLE; HIP ACETABULAR CUP CEMENTLESS

Model Number	01.38.054MH
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At 1 year and 7 months after the primary, the patient came in reporting pain due to a loose cup, which was caused by a pelvic fracture.The surgeon revised the medacta cup and liner with a competitor's products and revised the medacta head with a medacta head.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 06 may 2022.Lot 163196: (b)(4) items manufactured and released on 27-july-2016.Expiration date: 2021-07-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 2018.

• Brand Name: CUP: MPACT 3D METAL ACETABULAR SHELL Ø54 MULTI-HOLE
• Common Device Name: HIP ACETABULAR CUP CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14547059
• Report Number: 3005180920-2022-00421
• Device Sequence Number: 17800539
• Product Code: LPH
• UDI-Device Identifier: 07630040707930
• UDI-Public: 07630040707930
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K171966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2022

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: 07/13/2021
• Device Model Number: 01.38.054MH
• Device Catalogue Number: 01.38.054MH
• Device Lot Number: 163196
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/27/2016
• 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: 80 YR
• Patient Sex: Female