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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: LCP DISTAL HUMERUS PLATE/SCREWS PLATE, FIXATION, BONE

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SYNTHES GMBH UNK - CONSTRUCTS: LCP DISTAL HUMERUS PLATE/SCREWS PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Failure of Implant (1924); Unspecified Infection (1930); Necrosis (1971); Discomfort (2330); Non-union Bone Fracture (2369); Osteolysis (2377); Malunion of Bone (4529); Unspecified Tissue Injury (4559)
Event Type  Injury  
Event Description
Device report from synthes reports an event in finland as follows: this report is being filed after the review of the following journal article: kervinen k. V. , salmela m. T. , and lähdeoja t. A. (2022), outcomes of ao/ota c type fractures of the distal humerus after open reduction and internal fixation with locking plate constructs in patients at least 65 years old, bmc musculoskeletal disorders, vol. 23 (523), pages 1-10 (finland). The purpose of this retrospective cohort study was to evaluate the results of orif of ao/ota c-type (complete articular) distal humerus fractures treated exclusively with anatomic locking plates, in patients at least 65 years of age at the time of injury. Between june 2009 and (b)(6) 2016, a total of 39 patients (9 male and 30 were female; mean age of 75. 9 (65. 3-90. 2) years) were included in the study. All patients were treated with primary orif and bicolumnar plating. 3. 5 mm lcp distal humerus plates or 3. 5/2. 7 mm va lcp distal humerus plates (depuy synthes, usa) were used. The posterior paratripicital approach with olecranon osteotomy was used in all cases except 1. 35 olecranon osteotomies were closed with devices from an unknown manufacturer (k-wires and a tension band and 4 with a plate and screws). Cannulated screws, headless compression screws and bioabsorbable pins from unknown manufacturer were used to fix articular fragments as necessary. A total of 23 patients attended the follow-up. Mean follow-up time of participating patients was 3. 2 years (sd 1. 6; range 1 to 6. 2). The following complications were reported as follows: 2 patients died at 30-day (30-day mortality) due to causes we interpreted to be related to the injury and treatment: 1 patient died of perioperative myocardial infarction and 1 of pneumonia during post-injury stay in a rehabilitation hospital. During the follow-up period, 8 (21%) patients had died from unrelated causes, their mean lifetime after the injury was 2. 9 years (sd 1. 6) and their mean time from injury to patient file review was 4. 3 (2. 2) years. 4 patients had developed minor osteoarthritic changes since their previous radiograph taken during the primary treatment episode. There was 1 traumatic median and 2 traumatic radial nerve injuries, and 1 major iatrogenic ulnar nerve injury and 1 ulnar nerve entrapment after the surgery. 8 patients had 1-3 mm malreduction. 1 patient had 4-5 mm malreduction. 2 patients had suboptimal plate positioning leading to short and non-interdigitating screws. 8 (21%) fractures had united with no loss of reduction, but the olecranon osteotomy had widened (< 5 mm) before union. 6 patients had a minor secondary collapse of the distal humerus. 1 patient had a joint-destroying avascular necrosis (leading to tea). 1 patient had a loss of reduction (treated with tea). 1 patient had a deep infection leading to loss of reduction (which led to eventual resection of distal humerus and proximal ulna). 3 patients had minor and 2 patients had extensive osteoarthritic changes at this point. 5 patients had implant irritation and underwent 2 revision surgeries: late removal of tension band. 1 patient had implant irritation and underwent 2 revision surgeries: late removal of tension band and plates. 1 patient had a non-union of the olecranon osteotomy and underwent 2 revision surgeries (leading to a re-osteosynthesis of the osteotomy). 1 patient had orif failure by 6 weeks and underwent 2 revision surgeries: total elbow arthroplasty (with modest result: oes pain 56, function 75, s-p 50, total 60). 1 patient had technical difficulties in first surgery and underwent 3 revision surgeries. The patient underwent revision of failed orif, total elbow arthroplasty at nine months from the injury (with a good result: oes pain 100, function 100, s-p 75, total 92). 1 patient had postoperative wound dehiscence and underwent 3 revision surgeries. Wound revision and removal of olecranon plate five months from injury (wound healed, no outcome data, patient died during the follow-up period). 1 patient had deep infection with osteomyelitis and underwent 10 revision surgeries: removal of implants, multiple revisions, resection of osteomyelitic bone and eventually the joint. Led to an almost painless, but poorly functioning elbow (oes pain 81, function 44, s-p 31, total 52). This report is for an unknown synthes lcp distal humerus constructs. A copy of the literature article is being submitted with this report. This is report 1 of 2 for (b)(4).
 
Manufacturer Narrative
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. This report is for an unknown plates: lcp distal humerus plate/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k 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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Brand NameUNK - CONSTRUCTS: LCP DISTAL HUMERUS PLATE/SCREWS
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14840967
MDR Text Key295124205
Report Number8030965-2022-04406
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeFI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/28/2022 Patient Sequence Number: 1
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