MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/16HOLE/336MM/LT-STER; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.417S

Device Problem Break (1069)

Patient Problems Death (1802); Failure of Implant (1924); Sedation (2368); No Code Available (3191)

Event Type  Death  

Manufacturer Narrative

Additional narrative: patient weight is not available for reporting.It was reported that an obese, osteoporotic (b)(6) patient with a variable angle locking condylar plate (lcp) and a cortex screw, broke post-operatively requiring revision surgery.It was reported that the entire revision surgery took 4 hours.Subsequently, the patient passed away a few hours after the revision surgery was completed.At the time of this review, there was no information regarding cause of death nor causal relationship to the devices, therefore this will be conservatively reported as potentially related to synthes device.Date of event is unknown.Failure of implant reportedly occured the week before revision on (b)(6) 2016.Additional device product code: hrs and hwc.(b)(4).Device is expected to be returned for manufacturer review/investigation, but has not been received yet.Therapy date for concomitant devices is unknown.Reporter contact number (b)(6).(b)(4).Device history records review was completed for part # 02.124.417s, lot # 8999642.Manufacturing site: (b)(4), manufacturing date: jun 12, 2014, expiry date: jun 01, 2024.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 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 Description

Device report from synthes europe reports an event in (b)(6) as follow: it was reported that patient underwent initial implant procedure on (b)(6) 2015.On (b)(6) 2016, patient underwent hip revision procedure due to a variable angle locking condylar plate (lcp) and a cortex screw breaking post-operatively.During the revision procedure, a new plate with locking attachment plates was implanted and the broken cortex screw was removed with an extraction reamer.The revision procedure was only performed due to the plate breaking one week prior to (b)(6) 2016.The surgeon stated that the breaking of implants was possibly caused by the initial non-union fracture and stress-riser from the cerclage cable.The entire revision surgery took four (4) hours.Subsequently, the patient passed away few hours after the revision surgery was completed.Concomitant reported part: positioning pin (part # 298.803.01s, possible lot # 9488071 or 9466078, quantity: 1).Cerclage cable (part 298.801.01s, possible lot # 8056572, 9433804, 9644265 or 9633200, quantity: 1).This report is for one (1) 4.5mm va-lcp curved condylar plate/16hole/336mm/lt-ster.This is report 1 of 2 for com-(b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/16HOLE/336MM/LT-STER
• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6134661
• MDR Text Key: 61109190
• Report Number: 1000562954-2016-10214
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 02.124.417S
• Device Lot Number: 8999642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PART # 298.803.01S, LOT # UNKNOWN, QUANTITY: 1; PART 298.801.01S, LOT # UNKNOWN, QUANTITY: 1
• Patient Outcome(s): Death; Required Intervention