MAUDE Adverse Event Report: SYNTHES GMBH UNK - CABLE/WIRE; WIRE, SURGICAL

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

Patient Problem Inflammation (1932)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: vanryn, j.S., and verebelyi, d.M.(2002), one-stage debridement and knee fusion for infected total knee arthroplasty using the hybrid frame, the journal of arthroplasty vol.17 no.1, pages 1-6 (usa).We report 2 patients in whom a one-stage debridement and fusion for an infected tka was accomplished successfully with the use of a hybrid fixator.In 1997 and 1998, a hybrid fixator (synthes hybrid fixator system) was used for a one-step arthrodesis in 2 cases of infected total knee arthroplasty.One patient had rheumatoid arthritis, and the other had an infected reimplant arthroplasty.Neither patient was a candidate for reimplantation.Fusions were achieved with the hybrid frame in an average of 10 weeks.Patient 1: a 67-year-old female patient had a small local inflammation around 1 thin wire site cleared quickly after the wire was removed.All other local and systemic signs of infection resolved.Radiographs at 6 months showed a complete healing of the fusion and no erosive changes or ongoing osteomyelitis.At 24 months postarthrodesis, the patient showed no signs of pain or infection and was fully weight bearing on her fused knee with a walker.Patient 2: an 83-year-old female patient presented with severe pain in the left hip area 3 months postop.Bone scan identified a left femoral neck fracture.This fracture was treated successfully with a left hip hemiarthroplasty.Twelve weeks after the hip surgery, the patient was ambulating with a walker, and her erythrocyte sedimentation rate was 31 mm/h.At 37-month follow-up, the patient displayed a well-fused knee with a functioning left hip hemiarthroplasty.The patient was fully weight bearing with a cane and had no signs of pain or infection.This report involves one unk - cable/wire: trauma.This is report 1 of 2 for (b)(4).

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 cable/wire: trauma/unknown lot.Part and lot numbers are unknown; udi 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.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.

• Brand Name: UNK - CABLE/WIRE
• Type of Device: WIRE, SURGICAL
• 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: 15501206
• MDR Text Key: 300766220
• Report Number: 8030965-2022-07499
• Device Sequence Number: 1
• Product Code: LRN
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• 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: 11/04/2022
• 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: 67 YR
• Patient Sex: Female