MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT FACE-CHANGING 10 PE HC LINER 40/G; HIP SHELL LINER

Model Number	01.32.4052HC10A
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 february 2021: lot 1810856: (b)(4) items manufactured and released on 04-april-2019.Expiration date: 2024-03-19.No anomalies found related to the problem.To date, (b)(4) item of the same lot has been already sold without any other similar reported event.
Event or Problem Description
The patient came in reporting instability 7 months after the primary and the cause of the instability is unknown.The surgeon revised the face-changing 10° pe hc liner ø40/g with medacta dual mobility liner and revised the competitor head with a new competitor head.The surgery was completed successfully.

• Brand Name: MPACT FACE-CHANGING 10 PE HC LINER 40/G
• Common Device Name: HIP SHELL LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11364283
• Report Number: 3005180920-2021-00132
• Device Sequence Number: 883544
• Product Code: LPH
• UDI-Device Identifier: 07630040731270
• UDI-Public: 07630040731270
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K183582
• 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): 02/23/2021

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: 03/19/2024
• Device Model Number: 01.32.4052HC10A
• Device Catalogue Number: 01.32.4052HC10A
• Device Lot Number: 1810856
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention