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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
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| Model Number |
02.124.416 |
| Medical Device Problem Codes |
Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
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| Health Effect - Clinical Code |
Nonunion/Delayed-union Bone Fracture (2369)
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Type of Reportable Event
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Serious Injury
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Additional Manufacturer Narrative
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Product complaint #: (b)(4).Additional product code: hrs, hwc.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing 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.
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Event or Problem Description
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It was reported on an unknown date that the patient underwent a right total hip arthroplasty with removal of deep implants.It was reported that on (b)(6) 2019, the patient underwent an open reduction internal fixation right periprosthetic femoral shaft fracture.Discontinued using her walker, was ambulating independently.Unfortunately, she sustained another fall resulting in a distal femoral fracture and appeared to have a stable femoral component.On (b)(6) 2019, patient had periprosthetic femur fracture for an atrophic nonunion.The patient has had a previous it fracture with a dhs removed at the time of the hip surgery.Upon follow-up surgeon noted failure of plate at the fracture site indicative of nonunion.The patient outcome was unknown.This complaint involves eighteen (18) number of devices.This report is for (1) 4.5mm va-lcp curved condylar.This report is 1 of 18 for (b)(4).
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Additional Manufacturer Narrative
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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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.
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Additional Manufacturer Narrative
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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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6: the complaint device was not received for investigation.The image(s) was reviewed, and the complaint condition could be confirmed as the plate is seen to be broken.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot
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> the lot number is unknown, therefore no mre could be performed.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.
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Additional Manufacturer Narrative
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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.
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Event or Problem Description
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Additional event description: on (b)(6) 2019 a clinic reported that patient had a recent fall, and sustained a displaced fracture distal tip.Pain level is 4/10.On (b)(6) 2019, progress note reported that a fracture plate at the site of previous fracture.
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Additional Manufacturer Narrative
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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.H10 additional narrative: h6 given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the photo revealed that there was a plate and screw construct implanted in the right femur.It was observed that the plate was broken at the shaft.The broken fragments were observed in the provided evidence.No other problems identified.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for 4.5 va-lcp curved cond pl/16 hole/336/rt, p/n: 02.124.416.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.
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