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); Migration (4003)

Patient Problems Inadequate Osseointegration (2646); 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 3 that received revision when the stem was explanted at 2.3 months post initial implant for reason of subsidence and loose stem.The patient¿s age was (b)(6) and gender identity female.

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.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
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9443854
• MDR Text Key: 185227921
• Report Number: 1818910-2019-121863
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• 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 STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR