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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003); Unintended Movement (3026); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2005

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

"literature article entitled, ¿second-generation porous-coated cementless total hip arthroplasties have high survival¿ by christopher j.Chen, md, et al, published by clinical orthopaedics and related research (2006), no.451, pp.121-127, was reviewed.The purpose of this article was to retrospectively review 145 total hip arthroplasties implanted with a prodigy stem and a duraloc cup combined with a polyethylene liner, implanted between july 1993 and december 1994.Inclusion criteria for this study was a minimum of 5 years clinical and radiological follow-up.Revisions: 1 dislocation treated with head and liner revision.I dislocation secondary to a loose and migrated stem treated with revision of the stem, head, and liner.The dislocation was attributed to the loosened stem.There were no reported product problems with the liner and head that were revised to accommodate the newly implanted stem.The cup was well-fixed and left in situ.Radiographic findings: these findings were identified in progressive radiographic studies.There were no patient consequences, patient symptoms, nor did they require medical or surgical intervention.1 loose stem with minimal subsidence.2 hips with progressive spot welds on the acetabulum and femur.Osteolytic lesions found in 3 acetabulum and 7 femurs.These cases showed progressive polyethylene liner wear with femoral head penetration.Impacted depuy products: liner and head: implant dislocation.Femoral stem: implant loosening at the implant to bone interface, implant migration, inadequate osseointegration.Heath impact: surgical intervention and medical device removal.Femoral stem: implant loosening, implant migration, bone injury, inadequate osseointegration.Polyethylene liner: implant bearing wear, osteolysis.Health impact: no patient consequences.Symptoms: no adverse event.".

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.No product contribution was identified and no information received with this individual complaint indicates that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

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.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• 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
• MDR Report Key: 9631893
• MDR Text Key: 189365608
• Report Number: 1818910-2020-02994
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• 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
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1