MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/LEFT; PLATE,FIXATION,BONE

Model Number	02.124.417
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown.Additional classification code: jdp, hwc.Implant date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Therapy date of concomitant device is unknown.A device history record review was requested.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 on an unknown date the patient was implanted with a total knee prosthetic.The patient was implanted with (1) lcp curved condylar plate, (6) variable angle locking screws, (4) cortex screws self-tapping, (1) 1.0mm cable with crimp, and (5) 1.7mm cable with crimp.On an unknown date the patient is reported as having pain.On a follow-up visit it was discovered that the 16 hole condylar plate broke on the lateral side of the total knee where the spike from met the plate.All other implants were removed intact.The revision surgery was performed on the (b)(6) 2018.The patient was revised with a new plate.There is no report of patient harm and surgery completed successfully.Concomitant devices: 4 qty, p/n 214.822, l/n unknown; 6 qty, p/n 02.231.218, l/n unknown; 1 qty, p/n 298.800.01s, l/n unknown; 5 qty, p/n 298.801.01s, l/n unknown/ this is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Part: 02.124.417; lot: l611101; manufacturing site: mezzovico; release to warehouse date: 12.Oct.2017; the device history record shows this lot of 24 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and material quality criteria at the time of release with no issues documented during the manufacturing process.This implant was manufactured from forging blank 60061874 lot l606344 which was purchased from smb medical sa.The raw material certificate 3q3 was reviewed and the used material was according to iso-5832-1 specification for implants for surgery.Review of the device history record showed that there were no issues during the manufacture of this product which 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.

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/LEFT
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7596850
• Report Number: 2939274-2018-52490
• Device Sequence Number: 130814
• Product Code: HRS
• UDI-Device Identifier: 10886982042958
• UDI-Public: (01)10886982042958
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.124.417
• Device Catalogue Number: 02.124.417
• Device Lot Number: L611101
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 06/29/2018
• 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: 75 YR
• Patient Weight: 77