MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER Ø32/C; HIP SHELL POLYETHYLENE LINER

Model Number	01.32.3239HCT
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17.01.2019: lot 179359: (b)(4) items manufactured and released on 17-apr-2018.Expiration date: 2023-04-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Batch review performed on 17.01.2019: lot 178145:(b)(4) items manufactured and released on 21-mar-2018.Expiration date: 2023-03-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medacta medical affairs director: 1.5 years after primary cementless tha a partial revision is performed because of general pain.One xray was supplied but the date is unknown.The stem looks possibly undersized and potentially unstable, but only one projection is available and this is not enough to evaluate with certainty.The anteversion of the cup cannot be defined properly with this one projection and it has reportedly been corrected.The cause for the revision cannot be positively determined with the information at hand.
Event or Problem Description
Revision surgery performed after 1 year and 4 months from the primary due to pain.The cause of the pain is unknown.The surgeon revised the liner and stem to get more anteversion.The surgery was completed successfully.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø32/C
• Common Device Name: HIP SHELL POLYETHYLENE LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9676073
• Report Number: 3005180920-2020-00018
• Device Sequence Number: 2469435
• Product Code: LPH
• UDI-Device Identifier: 07630030811845
• UDI-Public: 07630030811845
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2020

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: 04/04/2023
• Device Model Number: 01.32.3239HCT
• Device Catalogue Number: 01.32.3239HCT
• Device Lot Number: 179359
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 02/06/2020
• 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