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U.S. Department of Health and Human Services

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

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SYNTHES GMBH UNK - CONSTRUCTS: LCP DISTAL FEMUR PLATE/SCREWS PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)
Event Type  Injury  
Event Description
This report is being filed after the review of the following journal article: paulsson, m. Et al. (2021), immediate full weight-bearing versus partial weight-bearing after plate fixation of distal femur fractures in elderly patients. A randomized controlled trial, geriatric orthopaedic surgery & rehabilitation, volume 12: 1¿14 (sweden). The purpose of this study was to compare the functional outcome between immediate full weight-bearing (fwb) as tolerated and partial weight-bearing (pwb) during the first 8 weeks following plate fixation of distal femur fractures in elderly patients. Between january 2013 and june 2016, 32 patients were enrolled in this study. Eleven patients were randomized to fwb and 21 patients to pwb, implant used was a stainless-steel lcp® distal femur plate (synthes, oberdorf, switzerland)patients were followed up at 8, 16, and 52 weeks. The following complications were reported as follows: fwb group: 1 patient died after 21 days after surgery and it was not directly related to the femur fracture or its treatment. 64% had peri-implant fractures. 1 patient had delayed union due to undetected atypical fracture. It was treated with non-operative treatment initially but ultimately addition of lag screws. There was union. 1 patient had screw tip protruding through the medial cortex of the femur condyle. It was exchanged to shorter screws. Pain and discomfort subsided. Pwb group: 3 patients died. 1 patient died of pulmonary embolism while still in hospital, the other deaths occurred at 182, and 364 days after surgery, none of them were directly related to the femur fracture or its treatment. 74% had peri-implant fractures. 1 patient had proximal screw breakage adjacent to thr. It was revised with proximal fixation with lateral attachment plate. There was union. 1 patient had deep infection. It was treated with debridement antibiotics implant retention. 1 patient had independent new fracture of the lateral femur condyle, 1 week postoperatively. The screw was removed distally. There was united distal femur fracture, poor knee function. 1 patient had screw tip protruding through the medial cortex of the femur condyle. It was exchanged to shorter screws. Pain and discomfort subsided. This report is for an unknown synthes lcp® distal femur plate/screws constructs. This report captures the reported events of peri-implant fractures, delayed union due to undetected atypical fracture and deep infection. This is report 1 of 3 for (b)(4).
 
Manufacturer Narrative
This report is for an unknown lcp® distal femur plate/screws constructs/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. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 FEMUR PLATE/SCREWS
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kate karberg
1302 wrights lane east
west chester, PA 19380
8472871282
MDR Report Key14416986
MDR Text Key291840524
Report Number8030965-2022-03234
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeSW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2022
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 Received05/02/2022
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: 05/17/2022 Patient Sequence Number: 1
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