MAUDE Adverse Event Report: HOWMEDICA OSTEONICS DALL-MILES CABLE SYSTEM; CERCLAGE, FIXATION

Device Problems Defective Component (2292); Naturally Worn (2988); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Failure of Implant (1924); Solid Tumour (4552)

Event Type  Injury  

Event Description

Patient was revised to addressed failed right total hip arthroplasty with acetabular bearing surface wear, pseudotumor and abductor deficiency of the right hip.There was a large volume of cloudy fluid removed approximately 50ml.There was a defect in the abductor tendon unit at the tip of the trochanter, extending across to the anterior margin with only a few fibers remaining intact to the trochanter attachment sites.Original implant date (b)(6) 2006.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DALL-MILES CABLE SYSTEM
• Type of Device: CERCLAGE, FIXATION
• Manufacturer (Section D): HOWMEDICA OSTEONICS
• MDR Report Key: 17527907
• MDR Text Key: 321139848
• Report Number: MW5134838
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1