MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: LISS; PLATE, FIXATION, BONE

Device Problem Device Slipped (1584)

Patient Problems Fistula (1862); Unspecified Infection (1930)

Event Date 09/01/2021

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.Pma/510k: this report is for an unknown device/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device avilable for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Devie evaluated by mfr and 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.

Event Description

This report is being filed after the review of the following journal article: kumar g.And dunlop c.(2021), femoral neck fracture to total femoral replacement: a case report, current orthopaedic practice, vol.32 (5), pages 535-540 (united kingdom).This study presents a case report of a 74-year-old female patient who underwent right tkr (unknown device) in september 1998.In october 1999, the patient had a trip and fall and underwent shs fixation (unknown device) for a right hip intertrochanteric fracture 31-a1.2 [ao foundation/orthopaedic trauma association (ao/ota) classification].Within a month, the lag screw cut-out (figure 1) was revised to a bipolar hemiarthroplasty (unknown device).One year later, the hip hemiarthroplasty stem was loose (figure 2).Investigations for infection were inconclusive.In may 2001, the patient underwent a two-staged revision right thr, with an s-rom® femoral stem (depuy, warsaw, indiana) (figure 2).In february 2003, the patient sustained an interprosthetic fracture distal to the femoral stem that was treated with a 13-hole liss® plate (synthes inc, west chester, pennsylvania) (figure 3).Thirteen months later, the patient developed a sinus on the lateral aspect of the thigh.Radiographs showed loosening of the plate and screws.Since the fracture was deemed to have healed, debridement and removal of plate was done.Samples did not grow any organisms.Within 1mo (may 2005), the patient sustained another fall and a fracture through one of the screw holes (figure 4).Distal femoral replacement (dfr) with a push-through stem over the distal end of the femoral stem of hip arthroplasty was done (figure 4).For a few months the patient was symptom free and developed a discharging sinus on the anterior aspect of the knee (figure 5).At this stage, the patient decided to have suppressive antibiotic therapy and continued to mobilize with the use of a walker.At regular follow-up, it was found that the acetabular cup was loose and had started to migrate proximally and was articulating with the lateral aspect of the iliac wing (figure 6).The current episode of inability to mobilize seemed to arise from the fact that the s-rom stem had dissociated from the metaphyseal sleeve and become unstable (figure 6).In view of the persistent chronic infection, a two-staged revision tfr was performed.In view of the several revision surgeries, antibiotics were continued for 6wk.All wounds healed well, and the patient made an uneventful recovery, mobilizing with full weightbearing using a walker.At 6-year follow-up, the patient (figure 11) was systemically well, mobilizing with a walker indoors, and managing most of the activities of daily living.This report is for an unk - plate: liss.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - PLATES: LISS
• Type of Device: PLATE, 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 Key: 15164611
• MDR Text Key: 297243241
• Report Number: 8030965-2022-05557
• Device Sequence Number: 1
• Product Code: HRS
• 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: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• 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
• Date Manufacturer Received: 07/08/2022
• 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
• Patient Age: 74 YR
• Patient Sex: Female