MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA EVOLIS RESURFACING PATELLA Ø39 MM; KNEE PATELLA RESURFACING

Catalog Number	3052.0039
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	11/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The new components implanted on (b)(6) 2017 are: femur standard cemented, ref 3010.204g lot n°157130.Insert standard 3040.0409 lot n° 130989.Tibial tray 3031.0204 lot n° 171280.Batch review performed on 13 november 2018: lot 132455: (b)(4) items manufactured and released on 06 june 2013.Expiration date: 2018-04-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Note: this component (patella resurfacing) was not revised.
Event or Problem Description
The patient complained of pain due to luxation of the patella noticed after radiological examination done 17 days after primary.Insert, femoral and tibial components implanted in (b)(6) 2016 were revised.The patella was left in place.Note: event happened in (b)(6) 2017 and notified in october 2018.

• Brand Name: EVOLIS RESURFACING PATELLA Ø39 MM
• Common Device Name: KNEE PATELLA RESURFACING
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8064119
• Report Number: 3005180920-2018-00887
• Device Sequence Number: 1947045
• Product Code: JWH
• UDI-Device Identifier: 07630030846564
• UDI-Public: 07630030846564
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2018

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: 04/30/2018
• Device Catalogue Number: 3052.0039
• Device Lot Number: 132455
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 11/13/2018
• 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
• Patient Age: 84 YR