This report is for an unknown proximal humeral locking plate (philos)/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Surgical/medical intervention; revision surgery.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.(b)(4).
|
This report is being filed after the review of the following journal article: robinsons, c.M., et al (2010), proximal humeral fractures with a severe varus deformity treated by fixation with a locking plate,the bone and joint journal, volume 92-b, number 5, pages 672-678 (unite kingdom) doi:10.1302/0301-620x.92b5.22849.This study aims to describe the anatomical features of fractures of the proximal humerus with varus deformity and an operative technique for its reduction and internal fixation (orif) and evaluate prospectively the functional and radiological outcomes from this treatment in a consecutive series of patients.Between march 2002 and february 2007, a total of 47 patients (21 male and 26 female) with a mean age at the time of operation was 57 years (22 to 88) who underwent open reduction and internal fixation (orif) were included in the study.Fixation was done using 3.5 mm cannulated screws (synthes, welwyn garden city, united kingdom) or acutrak screws (acumed, andover, united kingdom).Definitive fixation was achieved using a proximal humeral locking plate (philos plate; synthes).All the patients were reviewed prospectively by a research assistant at one and six weeks, three and six months and one and two years after their injury.The following complications were reported as follows: two patients developed symptomatic subacromial impingement and underwent open acromioplasty and removal of the metal.Two patients developed post-traumatic stiffness in a capsular pattern.Both were treated successfully by arthroscopic soft-tissue excision of scar tissue in the rotator interval, circumferential capsular release of the glenohumeral joint, excision of subacromial adhesions and acromioplasty.A case of a female patient with failure of fixation with recurrent varus deformity within two weeks of the operation.This patient underwent revision.This patient had subsequently developed stiff shoulders but were free from pain.A case of a female patient with failure of fixation,with recurrent varus deformity within two weeks of the operation, had malposition of the plate and low posteroinferior calcar screws had not been inserted into the lower quadrant of the head.This patient underwent revision surgery.This patient subsequently developed stiff shoulders but were free from pain.A case of a male patient developed progressive osteolysis of the greater tuberosity and had painless loss of active abduction, but with a full range of passive movement.Infraspinatus with atrophy was confirmed by arthroscopy.He underwent removal of the metal and subacromial decompression.His symptoms improved, but he had persistent pain-free restriction of active movement and weakness of the rotator cuff at the final follow-up.A case of a male patient with a mean age of 59 year old had asymptomatic patchy osteolytic and osteosclerotic changes in the humeral head without structural collapse or joint-space narrowing.A case of a male patient with a mean age of 59 year old had asymptomatic patchy osteolytic and osteosclerotic changes in the humeral head without structural collapse or joint-space narrowing.A case of a male patient with a mean age of 59 year old had asymptomatic patchy osteolytic and osteosclerotic changes in the humeral head without structural collapse or joint-space narrowing.A case of a female patient with a mean age of 59 year old had asymptomatic patchy osteolytic and osteosclerotic changes in the humeral head without structural collapse or joint-space narrowing.A case of a female patient with a mean age of 59 year old had asymptomatic patchy osteolytic and osteosclerotic changes in the humeral head without structural collapse or joint-space narrowing.(b)(4).This report is for an unknown proximal humeral locking plate (philos).
|