MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT HOODED PE HC LINER Ø36/F; HIP ACETABULAR LINER PE

Model Number	01.32.3648HCAT
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022.Lot 2003345: (b)(4) items manufactured and released on 06-july-2020.Expiration date: 2025-jun-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Addition component involved: ball heads: mectacer 01.29.210 biolox delta ceramic ball head 12/14 ø 36 size l + 4 (k112115) lot 2109348: (b)(4) items manufactured and released on 04-nov-2021.Expiration date: 2026-10-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
At 2 days after the primary left hip surgery, the patient's head dislocated from the liner in physical therapy.The surgeon converted the patient to a dm head and liner, revised the stem, and repositioned the cup and added 2 screws.The surgery was completed successfully.

• Brand Name: LINER: MPACT HOODED PE HC LINER Ø36/F
• Common Device Name: HIP ACETABULAR LINER PE
• 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: 14019141
• Report Number: 3005180920-2022-00245
• Device Sequence Number: 14111307
• Product Code: LPH
• UDI-Device Identifier: 07630030812125
• UDI-Public: 07630030812125
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 04/06/2022

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: 06/24/2025
• Device Model Number: 01.32.3648HCAT
• Device Catalogue Number: 01.32.3648HCAT
• Device Lot Number: 2003345
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2020
• 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: Male