MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/LEFT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number	02.124.407
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: patient height was reported as (b)(6).Patient date of birth was not provided for reporting.Date of event is unknown.Additional device codes used hrs, hwc.Exact date of implant procedure is unknown.Device is not expected to be returned for manufacturer review/investigation.Therapy date of concomitant device is unknown.Device history records review was completed for part # 02.124.407, lot # 9277313.Manufacturing location: (b)(4), manufacturing date: dec 03, 2014.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that a patient reported in emergency room with an aspiration of joint and revealed infection.The patient had total knee arthrodesis approximately nineteen (19) years prior and open reduction internal fixation for supracondylar periprosthetic femur fracture approximately two (2) years prior to the reporting date.Patient underwent revision procedure on (b)(6) 2017 when all hardware was removed and an antibiotic space was inserted.Concomitant medical devices: supracondylar periprosthetic devices (part# unknown, lot# unknown, quantity unknown).This report is for one (1) 4.5mm va-lcp curved condylar plate.This is report 1 of 3 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/LEFT
• Common Device Name: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• MDR Report Key: 6405945
• Report Number: 1000562954-2017-10027
• Device Sequence Number: 18974089
• Product Code: JDP
• UDI-Device Identifier: 10886982042750
• UDI-Public: (01)10886982042750(10)9277313
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2017

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: Physician
• Device Catalogue Number: 02.124.407
• Device Lot Number: 9277313
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2017
• Initial Report FDA Received Date: 03/15/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SUPRACONDYLAR PERIPROSTHETIC DEVICES
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 46