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

Model Number	01.32.3652HCT
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022.Lot 2004205: 36 items manufactured and released on 23-jul-2020.Expiration date: 2025-07-12.No anomalies found related to the problem.To date, 30 items of the same lot have been sold without any similar reported event during the period of review.Other components involved: ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 (k112115) lot.2115382: 149 items manufactured and released on 14-feb-2022.Expiration date: 2027-02-02.No anomalies found related to the problem.To date, 104 items of the same lot have been sold without any similar reported event during the period of review.Cup: mpact 01.32.160sh acetabular shell ø60 no-hole (k132879) lot.2105774: 46 items manufactured and released on 25-aug-2021.Expiration date: 2026-07-28.No anomalies found related to the problem.To date, 25 items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
The patient came in reporting pain due to a hematoma.At 1 week post primary the surgeon explanted the head and liner and in the process, the cup spun out.The surgeon performed a washout and revised the head, liner and cup and the surgery was completed successfully.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø36/G
• Common Device Name: HIP ACETABULAR 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: 15037299
• Report Number: 3005180920-2022-00537
• Device Sequence Number: 14815329
• Product Code: LPH
• UDI-Device Identifier: 07630030812156
• UDI-Public: 07630030812156
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103721
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2022

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: 07/12/2025
• Device Model Number: 01.32.3652HCT
• Device Catalogue Number: 01.32.3652HCT
• Device Lot Number: 2004205
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2020
• 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 Age: 71 YR
• Patient Sex: Male