MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 L; FEMORAL COMPONENT CEMENTED

Catalog Number	02.12.0002L
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2018: lot 146803 16 items manufactured and released on (b)(6) 2014.Expiration date: 2019(b)(6).No anomalies found related to the issue.To date, 16 items of the same lot have been already sold without any similar reported event.Investigation performed by patient match department on (b)(6) 2018: no extra-analysis is possible, since we did not receive any x-ray.Our analysis of the my knee process of this case found no deviations from the standard procedures.Each step has been performed correctly.On (b)(6) 2018 my knee dept reported also the following comments: the reported issue of the residual valgus cannot be related to the planning, as no residual valgus was set for the case.Reviewing the images used for the planning, the reported issue of a too large femur size is not confirmed the notching is not linkable to any of the two issues reported in the complaint (oversizing of the femoral component and residual valgus alignment of the femur).
Event or Problem Description
This surgeon did a bilateral surgery on (b)(6) 2017.Post-operatively he noticed that the patient's femoral component appeared to be calculated by the computer to be too large.In addition, it also seemed that the myknee blocks placed the femur in a greater valgus position than when he uses instruments.The surgeon decided to observe this patient over the next few months.The patient came in complaining about their knee not feeling straight.The surgeon downsized the femur from size 2 to 1 (ref 02.07.2401l rev.Femur p.S.Cemented left s1); the new liner implanted was ref (b)(6) insert semiconstrained 14mm s2 (so 3mm thicker).The surgery was completed successfully.

• Brand Name: FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 L
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7276210
• Report Number: 3005180920-2018-00048
• Device Sequence Number: 13926421
• Product Code: JWH
• UDI-Device Identifier: 07630030825798
• UDI-Public: 07630030825798
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• 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
• Report Date (Section B): 02/16/2018

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: 09/30/2019
• Device Catalogue Number: 02.12.0002L
• Device Lot Number: 146803
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 02/16/2018
• 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: 52 YR