MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: 4.5MM VA LCP CONDYLAR PLATE; CONDYLAR PLATE FIXATION IMPLANT

Catalog Number UNK - PLATES: 4.5MM VALCP COND

Device Problem Break (1069)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

Reference (b)(4).Literature citation: ward t.R.W., garala k., and riemer b.(2021), failure of dual plating in a complex open distal femur fracture as the result of major trauma, bmj case report, vol.14 (e245362), pages 1-4 (united kingdom).Complainant part is not expected to be returned for manufacturer review/investigation.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: ward t.R.W., garala k., and riemer b.(2021), failure of dual plating in a complex open distal femur fracture as the result of major trauma, bmj case report, vol.14 (e245362), pages 1-4 (united kingdom).This study presents a case report of a (b)(6) male patient who sustained multiple injuries with the most significant being an open distal comminuted metaphyseal femoral fracture with intra-articular extension, orthopaedic trauma association (ota) 33c2.3 (figure 1).He also had an ipsilateral open tibial plateau fracture.On presentation, he had a small, approximately 1×1 cm in-out wound over the proximal tibia with a small amount of degloving and abrasion to the skin over the anteromedial proximal tibia.He was managed as per hospital protocols and received intravenous antibiotics within 1 hour of admission.Dual plating open reduction internal fixation to his distal femur was performed using a synthes variable angle (va) distal femur plate (4.5 mm screws) fixed on the lateral side and the medial side was stabilised with a contralateral synthes distal tibia plate (2.7/3.5 mm screws).There is currently no contoured medial distal femoral plate for us in fracture fixation on the market.There was a large area of medial column bone loss which was filled using allograft (figure 2).Four months after the injury, he developed a post-traumatic deep vein thrombosis in his right femoral/popliteal vein and was commenced on warfarin for this.This was despite being prescribed anti embolic stockings and prophylactic dose enoxaparin during his 6-week admission and was also discharged with enoxaparin.Repeat radiographs at 5 months showed that two proximal screws in the medial plate had broken, however, the fixation was not compromised (figure 3).On his 10-month check-up repeat imaging showed that two proximal screws in the lateral plate had broken over and above the previous broken screws on the medial side.There was concern that the bone defect may be developing non-union with a risk of needing further surgery.A ct scan showed that the lateral side of the femur was uniting; however, there remained a large defect anteriorly on the medial side, where the initial bone loss was.Sixteen months postsurgery, the patient presented with knee pain and subsequent imaging showed a break in the lateral femoral plate with further breaking of screws resulting in fracture displacement and resulting in a flexion and varus deformity (figure 4).Due to the failure of dual plating, he was subsequently admitted for removal of all metal work and insertion of a retrograde intramedullary nail in conjunction with a new lateral plate and bone grafting.The most recent radiographs taken 15 months postrevision surgery show that the bone has started to heal with evidence of callus formation (figure 5).At his latest follow-up appointment, the patient reports a massive improvement in pain and mobility.The patient reports that he is still using a stick intermittently but is improving with ongoing physiotherapy.This report is for an unknown synthes 3.5 mm screws, unknown synthes 4.5 mm screws, and unknown synthes lateral va distal femur plate.

• Brand Name: UNK - PLATES: 4.5MM VA LCP CONDYLAR PLATE
• Type of Device: CONDYLAR PLATE FIXATION IMPLANT
• 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: 14119680
• MDR Text Key: 289423344
• Report Number: 8030965-2022-02465
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• 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 Received: 04/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - PLATES: 4.5MM VALCP COND
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN ALLOGRAFT
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male