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

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

Patient Problems Hematoma (1884); Unspecified Infection (1930); Ambulation Difficulties (2544); Fluid Discharge (2686); Skin Inflammation/ Irritation (4545); Insufficient Information (4580)

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.D1, d2, d3, d4, g4-510k: this report is for an unknown locking compression plate construct/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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: friedman, l.G.M., rothberg, d., & horwitz, d.S.(2022), staged knee arthrodesis using unilateral locked compression plating: a treatment for recurrent chronic knee infection, techniques in orthopaedics volume 37, number 2, pages 119-123 (usa).Presented, was a series of 12 patients who underwent fusion using a staged protocol.During the study period, a total of 12 patients with a mean age of 60.6 years, were included in the study.11 of these patients had failure of tka secondary to infection and 1 after chronic, recalcitrant septic knee with chronic periarticular osteomyelitis from a failed arthroscopic procedure.Each patient was taken to the operating room and had an open arthrotomy, removal of all remaining total knee components if present.There was an average of 6 weeks between stage 1 and stage 2 for 11 patients, with the sole patient without history of arthroplasty and with chronic periarticular osteomyelitis being treated with a single-stage fusion.All patients were treated with culture-tailored intravenous (iv) antibiotics between stages.All patients were treated with a broad 4.5 mm locking compression plate (synthes paoli, pa).10 patients had iliac crest bone used for bone graft.In addition, 2 patients were also treated bmp bone graft substitute, while 1 patient was treated with only bmp and no iliac crest autograft.Final follow-up averaged to 37 weeks.The following complications were reported as follows: 1 patient with a chronic recurrent infection, morbid obesity, and general deconditioning was unable to regain the ability to ambulate.1 patient had a postoperative hematoma drained, 1 patient had persistent infection with wound breakdown treated with repeat irrigation and debridement and a wound vac, eventually requiring a skin graft with resolution of infectious symptoms.2 patients required removal of screws due to implant irritation.1 patient was treated with 3 repeat irrigation and debridement procedures and removal of hardware for persistent infection; his infection was never eradicated, and he had chronically drained wounds.This patient was the only patient with persistent infection at final follow-up.This report is for an unknown synthes locking compression plate construct.A copy of the literature article is being submitted with this medwatch.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: LCP
• Type of Device: PLATE, 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 Key: 18822360
• MDR Text Key: 336740302
• Report Number: 8030965-2024-03111
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/01/2024
• 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