MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/80MM; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Model Number	02.231.280
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product codes: hrs and hwc.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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
Customer quality unit received a maude report forwarded from department of human services; this report is against user facility report mw5074624.Only additional and/or corrected information will be contained in this report.A copy of the maude event report is attached.It was reported that on an unknown date approximately three years ago, patient was implanted with one (1) unknown total knee arthroplasty (tka) construct (manufacturer unknown).On (b)(6) 2016, patient underwent implant procedure to treat loss stress femure fracture.Patient was implanted with one 4.5 mm (1) variable angle (va) curved condylar plate, eight (8) 5.0 mm va locking screws, one (1) 5.0 mm cannulated va locking screw, one (1) 4.5 mm cortex screw.Subsequently, on an unknown date, just fifty-one (51) days after the patient being released to a full weight bearing status, the plate broke and the patient developed a nonunion and the bone had re fractured.On (b)(6) 2017, patient underwent revision surgery.The surgeon went into surgery with the plan to not remove the implants, but subsequently, ended up removing all implants.The surgeon cut out the tissue surrounding the plate and the plate was still stuck.Subsequently, the surgeon could remove all implants successfully and then sent the plate and tissue for cultures due to a possible infection.During the revision, the patient's initially implanted tka construct was also removed completely.The patient was revised to an unknown zimmer segmental system, cutting out a portion of the femur.An unknown rod was also reportedly inserted in the knee joint and in the tibia.The revision was successfully completed, however, the patient's condition immediately after the revision surgery was not reported.The patient has been reported to have been involved in two (2) more surgeries since the initial implant of the synthes 4.5 mm va curved condylar plate construct, and is currently reported to have another infection at the implant site, this time around zimmer implants.This incident involves eleven (11) parts.(b)(4) captures first six (6) parts and (b)(4)captures remaining five (5) parts.Articles reported in in maude mw5074624 are captured under (b)(4).This report is for one (1) 5.0mm variable angle lockng screw/slf-tpng/strdrv/80mm.This is report 4 of 5 for (b)(4).

• Brand Name: 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/80MM
• Common Device Name: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7327942
• Report Number: 2939274-2018-50972
• Device Sequence Number: 145287
• Product Code: JDP
• UDI-Device Identifier: 10886982062239
• UDI-Public: (01)10886982062239(10)LOT#UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2018

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 Model Number: 02.231.280
• Device Catalogue Number: 02.231.280
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 03/09/2018
• 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