MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: LCP DISTAL HUMERUS PLATE; PLATE, FIXATION, BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

Brand name, common device name, manufacturer name, city, and state, lot #, pma/510k: 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.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr and manufacture date: 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: rollo, g.Et al (2021), open reduction and internal fixation using double plating with biological and artificial bone grafting of aseptic non-unions of the distal humerus: clinical results, strategies trauma limb reconstruction, vol.16 (3), pages 144¿151 (netherlands).The aim of this retrospective case series is to report the authors' prospective medium-term outcomes of the treatment of intra-articular, distal humeral aseptic non-union using orif with allograft bone grafting.A total of 16 patients (mean age of 44 years [range, 18-84 years]) were included in the study.After renewed reduction, fixation was performed using two plates (lcp®, depuy synthes¿, oberdorf, switzerland).Six patients received orthogonally placed plates and 10 patients parallel plates because of their fracture pattern.The mean follow-up period was 43 months (range, 24-62 months).The following complications were reported as follows: an 18-year-old male patient underwent an open arthrolysis 9 months after union because of capsular contractions.A 39-year-old male patient had skin infection/superficial wound infection successfully treated with antibiotics.A 45-year-old male patient underwent an open arthrolysis 4 months after union because of capsular contractions.A 42-year-old female patient underwent an open arthrolysis 5 months after union because of capsular contractions.A 39-year-old male patient had skin infection/superficial wound infection successfully treated with antibiotics; underwent an open arthrolysis 4 months after union because of capsular contractions.A 29-year-old male patient underwent an open arthrolysis 6 months after union because of capsular contractions.A 52-year-old male patient underwent an open arthrolysis 6 months after union because of capsular contractions.An 84-year-old male patient had skin infection/superficial wound infection successfully treated with antibiotics.This patient had neurological deficit existed pre-operatively which did not improve.This patient was the only one not to return to their preoperative functional level.A 36-year-old male patient underwent an open arthrolysis 3 months after union because of capsular contractions.A 58-year-old female patient underwent an open arthrolysis 5 months after union because of capsular contractions.A 56-year-old male patient had skin infection/superficial wound infection successfully treated with antibiotics; underwent an open arthrolysis 6 months after union because of capsular contractions.This report is for an unknown synthes lcp distal humerus plate/screws.This is report 13 of 18 for (b)(6).

• Brand Name: UNK - PLATES: LCP DISTAL HUMERUS PLATE
• Type of Device: PLATE, 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 Key: 14854420
• MDR Text Key: 295113913
• Report Number: 8030965-2022-04469
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention