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

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

Patient Problem Pain (1994)

Event Date 10/29/2018

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.This report is for an unknown cable/wire/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is lawyer.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

On (b)(6) 2018, the patient had a revision of right total hip arthroplasty to address failed right total hip.During the procedure the surgeon observed a ¿broken¿ fractured femoral neck.The liner had some signs of oxidation.The liner, femoral head and femoral stem were revised.The surgeon reported that there was a greater trochanter fracture that occurred during the preparation of new stem and a cable and synthes trochanteric fracture plate and 2 cables were used to stabilize the fracture.On (b)(6) 2021 medical records note the patient reports muscle spasms in the hip, thigh, and difficulty with ambulation.On (b)(6) 2023 medical records note the patient has low back pain, difficulty with ambulation, and right hip pain and a sharp aching numbness pressure in low back radiating out to the left hip while walking.Patient reports taking oral anti-inflammatory medication, having chiropractic manipulations and acupuncture to manage pain.The impression from the doctor was that the patient had levorotarory scoliosis with some degeneration and spondylosis of the lumbar spine and is status post hip replacement surgery.This is report 1 of 2 for (b)(4).This report is for unknown cable/wire.Complaint is linked to (b)(4).

• 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: 16797212
• MDR Text Key: 313843977
• Report Number: 8030965-2023-05175
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2023

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
• Initial Date Manufacturer Received: 04/03/2023
• Initial Date FDA Received: 04/24/2023
• 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: 56 YR
• Patient Sex: Female
• Patient Race: White