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

Catalog Number UNK HIP FEMORAL AUGMENT

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 11/21/2011

Event Type  Injury  

Manufacturer Narrative

(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

"the literature article entitled, ""femoral stem fracture and in vivo corrosion of retrieved modular femoral hips"" written by j.Caitlin huot carlson, ms, douglas w.Van citters, phd, john h.Currier, ms, amber m.Bryant, be, michael b.Mayor, md, and john p.Collier, de published by the journal of arthroplasty vol.27 no.7 2012 accepted by publisher 21 november 2011 was reviewed.The article's purpose was to report on retrieved modular femoral stems and inspect for corrosion.All stems were srom stems.Article reports that femoral heads were ceramic or metal.Liners may have been metal, ceramic or poly and the cups are not identified but assumed to be depuy implants.Inspection revealed that most stems had some degree of 'fretting' or corrosion at modular junctions including stem and sleeve interface or (and) stem and head junction.However the article does not quantify the findings to modular junction locations in order to determine accurate quantities.Table 1 provided further detail of reasons stems were explanted.Each case is captured individually for reason of revision and any information provided in the table and article in linked complaints." this complaint captures case no 40 that received revision when the stem was explanted at 160.7 months post initial implant for reason of stem implant fracture.The patient¿s age was not provided and gender identity female.

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.H10 additional 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.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 AUGMENT
• Type of Device: HIP FEMORAL AUGMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9446482
• MDR Text Key: 185482420
• Report Number: 1818910-2019-122136
• 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
• Report Date: 11/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL AUGMENT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention