MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT 01.32.3241HCAT HOODED PE HC LINER Ø32/D

Model Number	01.32.3241HCAT
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 december 2021: lot 2009619: 40 items manufactured and released on 01-dec-2020.Expiration date: 2025-11-17.No anomalies found related to the problem.To date, 18 items of the same lot have been sold without any similar reported event.Additional implant involved: mectacer 01.29.207 biolox delta ceramic ball head 12/14 ø 32 size xl +7 (k112115) lot.19c0046 batch review performed on (b)(4) 2021: lot 19c0046: 82 items manufactured and released on 20-nov-2019.Expiration date: 2024-11-10.No anomalies found related to the problem.To date, 36 items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient came in reporting pain due to a dislocation of the head from the liner that occurred when the patient was getting up from a seated position.At 2 months from revision the surgeon revised the cup, head, and liner.The surgery was completed successfully.

• Brand Name: MPACT 01.32.3241HCAT HOODED PE HC LINER Ø32/D
• Common Device Name: HOODED PE HC LINER
• 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: 13289791
• Report Number: 3005180920-2022-00020
• Device Sequence Number: 11864529
• Product Code: LPH
• UDI-Device Identifier: 07630030811869
• UDI-Public: 07630030811869
• 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: 2021
• Device Explanted Year: 2021
• 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): 01/19/2022

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: 11/17/2025
• Device Model Number: 01.32.3241HCAT
• Device Catalogue Number: 01.32.3241HCAT
• Device Lot Number: 2009619
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2020
• 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