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

Catalog Number	01.32.3644HCT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 september 2023.Lot 2247620: 100 items manufactured and released on 16-feb-2023.Expiration date: 2028-01-31.No anomalies found related to the problem.To date, 90 items of the same lot have been sold with no similar reported event during the period of review.Additional item involved in the event, batch review performed on 25 september 2023.Ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot.2308475.Lot 2308475: 90 items manufactured and released on 02-may-2023.Expiration date: 2028-04-04.No anomalies found related to the problem.To date, 75 items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
At 6 weeks from the primary, the patient came in reporting pain due to a dislocation of the head from the liner and the cause is unknown.The surgeon revised the cup and liner.The surgery was completed successfully.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø36/E
• Common Device Name: FLAT PE LINER
• 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: 17973641
• Report Number: 3005180920-2023-00795
• Device Sequence Number: 14707637
• Product Code: LPH
• UDI-Device Identifier: 07630030812118
• UDI-Public: 07630030812118
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 10/20/2023

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 Catalogue Number: 01.32.3644HCT
• Device Lot Number: 2247620
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2023
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 45 KG