MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2005

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

"literature article entitled, ¿survivorship of the charnley elite plus cemented femoral stem¿ by m.Roswell, et al, published by international orthopaedics (2005), vol.29, pp.214-218, was reviewed.This study reviews our survivorship of the charnley elite plus femoral stem at a mean of 57 months post implantation across a single nhs hospital trust.Implanted depuy products: 268 cemented charnley elite plus femoral stems and depuy femoral heads.Depuy cmw cement was used in 3 stems.The remaining charnley stems were cemented with competitor cement.The authors do not provide information regarding the manufacturer or the outcomes of the acetabular cups.Results: 2 stems and heads revised for infection.4 stems revised for recurrent dislocations- there was no reported product problem with the stem.5 stems revised for aseptic loosening.1 stem revised to treat a periprosthetic fracture sustained during a motor vehicle accident.The fracture is attributed to the mva.There was no reported product problem with the femoral stem.47 cases of mispositioned stems and femoral osteolysis identified on progressive radiographic studies.Treatment for this is unknown.The authors specifically attribute the osteolysis to the tip of the stem coming into contact with the posterior femoral cortex creating friction that led to the progressive osteolysis.Captured in this complaint: charnley elite plus femoral stem: implant mispositioned.Cmw cement: implant loosening of an unknown interface.Patient harms: osteolysis, infection, surgical intervention, medical device removal.".

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9473009
• MDR Text Key: 187942527
• Report Number: 1818910-2019-123139
• Device Sequence Number: 1
• Product Code: KXA
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1