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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 Problem Non-union Bone Fracture (2369)
Event Type  Injury  
Event Description
This report is being filed after the review of the following journal article: garala k. , et al (2022) distal femoral fractures: a comparison between single lateral plate fixation and a combined femoral nail and plate fixation, injury 53 (2022) 634¿639 (united kingdom). This study aims to compare outcomes of fixation of distal femoral fractures using single lateral plate (slp) fixation versus nail and plate fixation (npf) for primary fracture fixation. Between august 2016 to august 2020, patients with previous fixation for femoral neck fractures or metalwork from hip or knee arthroplasty were included in the study. 67 patients with distal femoral fractures (3 bilateral) were treated by slp or npf. 3 patients were excluded as they had complex open fractures with significant bone loss. Therefore 64 patients were included in the study (17 males and 47 females). The age range was 22 to 102 years old with a mean age of 68 years. Patients were divided into 2 operative groups: slp with 40 patients (13 males and 27 females) and npf with 27 patients (5 males and 22 females). 2 patients in the npf group and 1 patient in the slp group were bilateral. During single lateral plating (slp), fixation was achieved using a synthes distal femoral locking condylar plate (lcp) (west chester, pa 19380) or the synthes variable angled locking condylar plate (va-lcp) (west chester, pa 19380) augmented with cables or screws outside the plate where deemed necessary. For nail and plate fixation (npf). Combined retrograde femoral nailing and lateral plating (minimally invasive lateral incisions for the plate) were performed in all cases. The implant used for npf was the titanium synthes expert retrograde/anterograde femoral nail (west chester, pa 19380) and synthes variable angled distal femur lcp. The average follow-up time was 29 months (range from 6 to 56 months). Slp group: -1 30-day mortality. There were 11 non-unions. All required revision surgery. -5 other return to theatre including manipulation under anesthetic for stiffness debridement and washout for wound infection. 7 patients experienced subsequent metalwork failure due to a non-union. Fig. 3 demonstrates an example of a well reduced fracture treated by slp which subsequently didn¿t unite, and the metalwork failed. Radiograph demonstrating a failure of plate fixation following satisfactory reduction and fixation. Npf group: 1 30-day mortality. 1 other returned to the theatre for the further procedure for backing out of a distal locking blade. This report is for an unknown synthes titanium synthes expert retrograde/anterograde femoral nail, unknown synthes variable angled distal femur lcp, unknown synthes distal femoral locking condylar plate (lcp), and unknown synthes variable angled locking condylar plate (va-lcp). This is report 1 of 3 for (b)(4).
 
Manufacturer Narrative
Patient identifier, age for date of birth, sex, weight: there are multiple patients. All known information is provided in the literature article. Brand name, common device name, manufacturer name, lot #, pma/510k: this report is for an unknown lcp distal femur construct/unknown lot. Part and lot number are unknown; udi number is unknown. Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation. Device evaluated, device 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.
 
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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 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14550568
MDR Text Key293074449
Report Number8030965-2022-03580
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2022
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: 05/31/2022 Patient Sequence Number: 1
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