MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R; CEMENTED FEMORAL COMPONENT

Catalog Number	02.12.0004R
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 july 2018.Lot 136421: (b)(4) items manufactured and released on 18 february 2014.Expiration date: 2019-01-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Other device involved: reference 02.12.0410fr (k121416) tibial insert fixed sphere flex #4/10 mm r.Lot 140355: (b)(4) items manufactured and released on 13 march 2014.Expiration date: 2019-01-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event clinical evaluation performed by medical affairs director on 18 july 2018: 4 years after primary cemented tka the surgeon decided to resurface the patella, upon receiving complaints from the patient.During surgery, the femoral component fixation was assessed to be insufficient and therefore it was exchanged to a new one.The causes for reoperation do not appear to be related to a malfunctioning device.
Event or Problem Description
Patient presented with patella femoral pain 4 years after primary [no patella resurfacing completed in primary case].Surgeon planned to resurface the patella and revise the liner, but during surgery the femoral component was found loose (it came off very easily), so it was replaced with a new one, same size 4 sphere.In addition, a new 12mm poly and a inset patella size 24 were implanted.
Additional Manufacturer Narrative
Preliminary investigation performed by r&d project manager on september 17, 2018: from the picture enclosed it can be seen that, after the explantation, no residual cement is present on the internal pockets of the femoral component.The finishing of the bottom surface of the femoral component seems to be in compliance with the specifications required, but it is very difficult to carefully evaluate it by a picture.Pockets to host the cement are present.No elements that can let us suppose a bad adhesion of the cement to the component can be identified.From the description of the event and from the picture enclosed we can't identify any possible root cause for the event.

• Brand Name: FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7702520
• Report Number: 3005180920-2018-00518
• Device Sequence Number: 732940
• Product Code: JWH
• UDI-Device Identifier: 07630030825842
• UDI-Public: 07630030825842
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2018

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: 01/31/2019
• Device Catalogue Number: 02.12.0004R
• Device Lot Number: 136421
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2018
• Supplement Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 10/17/2018
• 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: 70 YR
• Patient Weight: 80