DEPUY ORTHOPAEDICS INC US PFC*SIGMA/OV/DOME PAT 3PEG,35; SIGMA KNEE PRIMARY : KNEE PATELLA
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Model Number 96-0101 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bone Fracture(s) (1870); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Unspecified Tissue Injury (4559)
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Event Date 10/13/2022 |
Event Type
Injury
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Event Description
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(b)(6) 2022: the patient was squatting in therapy and felt a pop with increasing pain.Xray show a small nondisplaced fracture across the inferior pole of the patella.This is treated with a brace for six weeks.(b)(6) 2022: the patellar fracture remains stable.The patient c/o stiffness from wearing the brace and was told he can now do range of motion and walking.It is questionable whether he avulsed a little bit of the tendon from the bone.No further intervention planned at this time outside of slowly increasing his activity level.
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Manufacturer Narrative
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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.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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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