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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: VA-LCP PLATE, FIXATION, BONE

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SYNTHES GMBH UNK - CONSTRUCTS: VA-LCP 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  
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 constructs: va-lcp plate/screws/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.
 
Event Description
This report is being filed after the review of the following journal article: poelmann, j. And kloean, p. (2021), modified use of the proximal humeral internal locking system (philos) plate for distal femoral nonunions, european journal of orthopaedic surgery & traumatology, vol. Xx pages 1-9, (netherlands). The aim of our study was to report our results after use of a minimally invasively placed proximal humeral internal locking system (philos) plate as a medial buttress in the treatment of a distal femoral nonunion. A total of 15 patients (9 females and 6 males) with a median age of 68 (range 19¿81) underwent surgery for a dfn using the philos plate as a medial buttress between november 2013 and october 2019. Initial surgery was done for distal femoral fractures using a liss plate, dcs, and a lateral lcp. Median follow-up was 24 months (range 3¿56). The following complications were reported as follows: 1 patient died. Patient 2: a (b)(6) year-old male patient was treated with a liss plate which was revised to an ncb plate + allograft bone chips. The patient also had nonunion which was treated with 95-degree condylar blade plate + medial philos plate. Patient 3: a (b)(6) year-old male patient was treated with a lateral lcp which was revised to bone grafting with 2 allograft femoral heads (1), medial distal femur plate + right icbg + femoral head (2), removal of loose screws (3). The patient also had nonunion which was treated with 95-degree condylar blade plate + medial philos plate. Patient 4: a (b)(6) year-old male patient was treated with a liss plate which was revised to an incision + drainage (1,2), lateral va distal femur lcp + anterior lcp + icbg + dbx (3), incision + drainage (4), anterior plate removal + gentabeads (5), removal of gentabeads + antibiotic cement coated liss plate (6), debridement + antibiotic cement coated liss plate (7). The patient also had nonunion which was treated with va distal femur lcp + medial philos plate. Patient 5. A (b)(6) year-old male patient had nonunion after dcs. Nonunion was treated with liss plate + medial philos plate. Patient 6: a (b)(6) year-old male patient was treated with a liss plate which was revised to an which was revised to a va distal femur lcp + fibula allograft + dbx. The patient also had nonunion which was treated with 95-degree condylar blade plate + medial philos plate. Patient 7: a (b)(6) year-old male patient was treated with a liss plate which was revised to a 95-degree condylar blade plate + icbg. The patient also had nonunion which was treated with 95-degree condylar blade plate + medial philos plate. Patient 8: a (b)(6) year-old female patient was treated with a liss plate which was revised to a 95-degree condylar blade plate + icbg. The patient also had nonunion which was treated with va distal femur lcp + medial philos plate. Patient 9: a (b)(6) year-old female patient was treated with a lateral lcp + calciumphosphate which was revised to a 95-degree condylar blade plate + icbg + dbx. The patient also had nonunion which was treated with va distal femur lcp + medial philos plate. Patient 10: a (b)(6) year-old female patient had nonunion after va distal femur lcp treatment. Nonunion was treated with va distal femur lcp + medial philos plate. Patient 11: a (b)(6) year-old female patient was treated with a lateral lcp + homologous bone graft which was revised to an allograft croutons (1), icbg (2), + quadriceps release (3), 95-degree condylar blade plate + icbg (4), 95-degree condylar blade plate + icbg + dbx (5). The patient also had nonunion which was treated with a medial philos plate. Patient 14: a (b)(6) year-old female patient was treated with a liss plate which was revised to a liss plate + cerclage around prosthesis (1), reposition liss plate (2), croutons + icbg (3). The patient had second revision due to maplosttion of liss plate. The patient also had persistent nonunion. 3 patients needed additional surgeries to procure healing. Two received surgeries at respectively 2 and 6. 5 months after the index operation. One patient received additional posterior icbg and united after 9 months. The second patient also received posterior icbg with addition of three cancellous screws and united 2 months later. 1 patient underwent a judet quadricepsplasty for a stiff knee (arc of motion 30 degrees) one month after union was confirmed. 3 patients presented with a broken plate. This report is for an unknown synthes va-lcp plate/screws construct. This report captures the reported (b)(6) year-old female patient who had nonunion after va distal femur lcp treatment. Nonunion was treated with va distal femur lcp + medial philos plate. This is report 9 of 15 for complaint (b)(4).
 
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Brand NameUNK - CONSTRUCTS: VA-LCP
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 Key14428331
MDR Text Key291943112
Report Number8030965-2022-03265
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional,Company Representative
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 Received05/18/2022
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: 05/18/2022 Patient Sequence Number: 1
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