MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE PATELLA INSET Ø 24MM

Catalog Number	02.07.0041IP
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	02/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Preliminary investigation performed on 14 march 2018 by r&d product manager based on the pictures received: implants are no represented in the picture enclosed.No considerations can be done on the possible root cause of the event that, even from the description, doesn't seem to be implant related.
Event or Problem Description
Patient was complaining of pain in the knee 10 months after primary.Intra-operatively it was discovered the patient had severe arthrofibrosis and that scar tissue had grown over the 24mm inset patella, causing patello-femoral pain.The surgeon removed the scar tissue, removed the inset patella (not defective) recut and used a resurfacing patella size 1 to minimise pressure in the joint space.He also replaced the tibial polyethelene with the same size though there was no defect to the original.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director: patella inset revision surgery occurred 9 months after primary total knee replacement.The patient was complaining about pain.During revision surgery arthrofibrosis was found and identified as the cause of pain.There is no reason to suspect a faulty device.Batch review performed on (b)(6) 2018, lot 166891: (b)(4) items manufactured and released on (b)(6) 2016.Expiration date: 2021-11-24.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.

• Brand Name: GMK-SPHERE PATELLA INSET Ø 24MM
• Common Device Name: PATELLA INSET Ø 24MM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7338233
• Report Number: 3005180920-2018-00143
• Device Sequence Number: 1544720
• Product Code: JWH
• UDI-Device Identifier: 07630030815799
• UDI-Public: 07630030815799
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2018

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: 11/24/2021
• Device Catalogue Number: 02.07.0041IP
• Device Lot Number: 166891
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2018
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 04/12/2018
• 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: 59 YR