It was reported that a retrospective chart and x-ray review was performed on cases between 2002 and 2009, in which rhbmp-2 was used in acute trauma or post-traumatic reconstruction.These cases were then compared with a matched cohort without the use of bone morphogenetic protein-2.Group 1 was comprised a total of 193 patients whose treatment included rhbmp-2 (155 reconstructive and 38 acute open fractures).Group 2 was comprised 181 patients treated without the use of rhbmp-2 (145 reconstructive and 36 acute open fractures).If there was any mention of ¿seroma,¿ ¿abscess,¿ ¿erythema,¿ ¿drainage,¿ or ¿dehiscence¿ in the postoperative physical examination of any inpatient progress note or outpatient clinic note, a postoperative wound complication was recorded.Any administration of antibiotics given outside the standard 24-hour postoperative course, or 48 hours for open fractures, was considered prolonged antibiotic use.Reoperation rates and culture results from debridement procedures for postoperative wound complications were also recorded.In the bmp cohort, there was prolonged antibiotic therapy secondary to a postoperative wound complication documented in 17 patients (9%) in group 1 (2 in acute trauma cases, 15 in reconstructive cases).
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Article citation: chan et al.Wound complications associated with bone morphogenetic protein-2 in orthopaedic trauma surgery.J orthop trauma.2014 oct;28(10):599-604.Pts gender: mean age 52 yrs (range 16¿90).Implant date: between 2002 and 2009.(b)(6).(b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
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