MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.412

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Injury (2348)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

This report is for one (1) unknown plate.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.This report is for one (1) unknown plate.Pma/510(k) number is not available.Product was not returned.Device history records review could not be completed without lot number.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 Description

It was reported that on an unknown date, the patient had injuries caused by the implantation of distal femur periprosthetic locking plate.Patient outcome was not provided.This report is for one (1) unknown plate.This is report 1 of 2 for (b)(4).

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.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.

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.H4 device history, part: 02.124.412, lot: 9478411, manufacturing site: mezzovico, release to warehouse date: 26.May 2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.

Manufacturer Narrative

Product complaint # (b)(4).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.D2: additional pro-code: hrs, hwc.H3, h4, h6: a review of the device history record has been requested.D4: expiration date is unknown.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 Description

11/8/2019: updated event description: it was reported that on (b)(6) 2017, the patient fell and suffered a right distal femur fracture.After medical evaluation, it was determined that the patient needed to undergo an open reduction and internal fixation (orif) surgery to repair the fracture.On (b)(6) 2017, the patient had her first surgery.While the surgery was in the process, the sales consultant and the surgeon used a depuy orthopaedics variable angle locking condylar plate ("va-lcp") to stabilize the fracture site and promote refusion of the bone.The surgeon reduced the patient's right femur site as appropriate and then affixed the va-lcp to the femur with screws.Prior to surgery, the patient was never by instructed the sales consultant or hospital staff that sales consultant would be present in the operating room during the procedure nor did she gave her permission to be present prior to surgery.When the patient learned that the sales consultant had been in the operating room during surgery, she became embarrassed, extremely upset and experienced significant mental distress.After surgery, the patient underwent a period of recovery and rehabilitation and returned home on (b)(6) 2017.On or about (b)(6) 2017, the patient began experiencing severe pain around the site of the break in her right femur; the pain was so unbearable that the patient could not sleep.In addition to the severe pain, the patient also experienced difficulty walking.On (b)(6) 2017, the patient returned to the hospital for evaluation, where it was discovered after an x-ray that the va-lcp had broken.The locking plate of the va-lcp had broken in a location at or near the edge of the holes milled for placement of screws.When the surgeon told the patient and her husband that the va-lcp had snapped in half, they demanded that the parts removed from his wife be given to him.At this time, the couple were both informed that the sales consultant was present in the operating room at the time of the surgery and had taken the broken device with him.The patient became extremely embarrassed caused her emotional and mental distress that a man she did not know, who was not a doctor, nurse or hospital employee was in the room while she was unconscious and under anesthesia was there without her knowledge or express consent.The couple insisted that the pieces of the device be given to them and upon information and belief, they were retrieved from the sales consultant by the surgeon's office.On (b)(6) 2017, the patient underwent a revision surgery to her right distal femoral fracture.The surgeon first removed the va-lcp, and then, on advice of the sales consultant, performed another orif procedure by affixing a different va-lcp to the fracture site.Upon information and belief, in order to prevent a second device failure, however, upon the recommendation of the sales consultant, the surgeon utilized a different model of the va-lcp, which was thicker and had different screw hole placements.Upon information and belief another sales consultant was present in the operating room during the surgery and provided guidance to the surgeon on the use of the va-lcp.Prior to surgery, the patient spoke to the staff about the "sales guy" that was in the room at her first surgery and explicitly instructed the hospital staff that she did not want any sales consultant in the operating room during the procedure and she wanted the pieces of the broken device preserved and given to after the surgery.The patient got upset that her wishes had been disregarded and expressed embarrassment, and experienced significant mental distress when she learned that a sales consultant was present in the operating room during the surgery.After the surgery, the couple repeatedly asked for the pieces of the second failed device that they requested be preserved to no avail.After many inquiries, the couple were told that the pieces were taken by the other sales consultant and/or the pieces were destroyed and irretrievable.On (b)(6) 2017, the patient returned home from the hospital with a wheelchair to use.A few weeks later, on august 15, 2017, the patient went for a follow-up appointment with the surgeon, who stated that an x-ray taken that day looked satisfactory and that she need to use the wheelchair for six (6) to eight (8) more weeks.On (b)(6) 2017, the patient had another follow-up with the surgeon, who examined an x-ray and ct scan taken of the patient's right femur that day.The x-ray and ct scan showed that the patient's right femur was not healed, with cracks at the site of the original fracture.Two successive x-rays taken on (b)(6) 2017 and (b)(6) 2018 showed that the patient right femur was still not healed, with cracks remaining at the site of the original fracture.On (b)(6) 2018, the patient sought a second opinion from another surgeon, who performed an x-ray and ct scan.When the x-ray and ct scan showed little improvement, the surgeon advised that the patient's age and preexisting medical conditions made healing a more difficult and prolonged process, and to give the bone time to heal.On (b)(6) 2018 the patient experiencing severe pain at the site of the break, went for an appointment with the surgeon who performed an x-ray.After examining the x-ray, the surgeon informed the patient that the va-lcp he had implanted in (b)(6) 2017 appeared to have been crushed.The first surgeon then referred the patient to the third surgeon who ordered another revision surgery to remove the broken va-lcp and repair the fractured femur.After a ct scan on (b)(6) 2018, the patient was cleared for surgery.On (b)(6) 2018, the third surgeon performed a second revision (and third overall) surgery on the patient.The patient asked that the remains of the broken device be given to them once removed.Upon information and belief, based on the patient's age, weight and pre-existing conditions, the surgeon did not use a va-lcp, however, or perform an orif procedure; instead, the surgeon performed a distal femoral replacement arthroplasty.In contrast to stabilizing the fracture site with a plate such as the va-lcp, this procedure involved removal of the distal femur and replacing it with a prosthesis anchored to the remaining portion of the femur.The surgery was an apparent success, the patient began physical therapy on (b)(6) 2018.On (b)(6) 2018, the surgeon took an x-ray of the patient's right leg and removed the staples from the incision site.When the patient and her husband asked for the parts that were removed from her during this procedure, they were informed that they were lost by the hospital.Upon information and belief, the broken parts would ordinarily be given to the sales consultant who would take them back to the manufacturer with a report.Two days later, on (b)(6) 2018, the patient's right leg became severely swollen, with heat coming from the incision site.The patient was soon after placed on antibiotics to discourage infection.On (b)(6) 2018, the pain at the incision site became worse, and the patient noticed drainage from the incision wound.On or about (b)(6) 2018, the patient was diagnosed with a flesh infection of the leg at the site of the incision, and she began routine visits to a rehab center shortly thereafter.The infection caused an open wound to develop at the incision site which, for much of the healing process, discharged a foul-smelling pus.The patient subsequently spent eighteen (18) weeks receiving treatment from the rehab, receiving her final treatment on (b)(6) 2018.As a result of the infection and scarring at the former site of the wound.Throughout the process, the patient suffered a number of other related adverse effects, including physical and emotional pain and suffering.The patient's prolonged recovery that resulted from the multiple surgeries kept her confined to a wheelchair or to a couch in her home.Throughout her prolonged recovery, the patient felt like a prisoner trapped in her own body and in her own home.In addition, the patient could not perform everyday activities she had routinely performed and enjoyed, such as cooking, shopping, walking their dog, and driving.As a result, the patient became responsible for these duties while the patient recovered.While the patient recovered, the husband was responsible for cooking, cleaning, shopping, walking the dog, and driving, including driving the patient to her surgeries, numerous follow-up appointments with her surgeons and physicians, and regular physical therapy and rehabilitation appointments.This complaint involves one (1) device only.11/12/2019: update, this (b)(4) captures the first revision of the broken va-lcp was removed and performed another orif procedure by affixing a different va-lcp to the fracture site while (b)(4) captures the second revision involving the removal of the va-lcp plate.Additional information received on october 18, 2019 via email with the following information: on (b)(6) 2017, the patient began experiencing severe pain around the site (unbearable pain), difficulty walking.On (b)(6) 2017, the patient returned to the hospital for evaluation.X-ray revealed that va-lcp was implanted on (b)(6) 2017 and was broken.The locking plate of the va-lcp had broken (snapped in half) in a location at or near the edge of the holes milled for placement of screws.On (b)(6) 2017, the patient underwent a revision surgery to her right distal femoral fracture.The broken va-lcp was first removed and performed another orif procedure by affixing a different va-lcp to the fracture site.The patient asked for the pieces of the second failed device.On (b)(6) 2017, the patient returned home with a wheelchair use.On (b)(6) 2017, the patient had a follow-up visit and x-ray was taken and stated that it looked satisfactory.On (b)(6) 2017, x-ray revealed right femur was not healed, with cracks at the site of the original fracture.On (b)(6) 2017 and (b)(6) 2018, x-rays showed patient's right femur was not healed, with cracks remaining at the site of the original fracture.On (b)(6) 2018, the patient sought a second opinion from another surgeon.X-ray and ct scan showed little improvement, due to age and pre-existing medical conditions made healing more difficult.The patient experienced severe pain at the site of the break on (b)(6) 2018.X-ray revealed that the va-lcp that was implanted on (b)(6) 2017 have been crushed.On (b)(6) 2018, ct scan was done and surgery was scheduled for (b)(6) 2018.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: updated data-a1, a2, b6, b7 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/12 HOLE/266MM/RIGHT
• Type of Device: 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: 8245377
• MDR Text Key: 132979338
• Report Number: 2939274-2019-55832
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/18/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.412
• Device Lot Number: 9478411
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2018
• Initial Date FDA Received: 01/14/2019
• Supplement Dates Manufacturer Received: 11/08/2019; 11/20/2019; 11/20/2019; 02/04/2020
• Supplement Dates FDA Received: 11/13/2019; 11/20/2019; 11/20/2019; 02/05/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR