Additional narrative: this report is for an unknown lcp construct/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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.
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This report is being filed after the review of the following journal article: nam, d.J.Et al.(2022), fractures of the distal femur in elderly patients: retrospective analysis of a case series treated with single or double plate, journal of orthopaedic surgery and research, vol.17:55, pages 1-8 ((b)(6)).From may 2004 to june 2018, a total of 82 cases of distal femoral fractures were included in this retrospective study.Group a consisted of 42 patients who underwent single-plate fixation.Group b consisted of 40 patients who underwent double-plate fixation.The mean patient age was 77 years (67¿87 years) and 76 years (64¿86 years) in groups a and b, respectively.The implants used were an lcp and a tomofix-medial distal femur plate.The radiologic results were examined using anterior¿posterior radiography of the distal femur and lateral and oblique radiography at 3, 6, 12, 24 weeks, 1 year, and last follow-up, even after bone union was confirmed.The following complications were reported as follows: group a: 1 case had metal failure and had revision surgery.8 cases had wound infection which was treated with irrigation and debridement.Group b: 1 case had nonunion so autobone graft was performed through revision operation.2 cases had wound infection which was treated with irrigation and debridement.This report is for an unknown lcp construct.This is report 2 of 2 for (b)(4).A copy of the literature article is being submitted with this medwatch.
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