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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN DEPUY FEMORAL STEM; HIP FEMORAL STEM/SLEEVE
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DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN DEPUY FEMORAL STEM; HIP FEMORAL STEM/SLEEVE Back to Search Results
Catalog Number UNK-HIP
Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problems Cyst(s) (1800); Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Necrosis (1971); Pain (1994); Weakness (2145); Discomfort (2330); Joint Disorder (2373); Confusion/ Disorientation (2553); No Code Available (3191)
Event Date 10/27/2015
Event Type  Injury  
Manufacturer Narrative
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.
 
Event Description
Litigation alleges patient suffers from metallosis.Update 2/18/16-pfs and medical records received.After review of the medical records for mdr reportability, a dor was provided.The patient was revised for metallosis and malpositioned cup.A progress note from (b)(6) 2015 indicated metal ion levels above 7ppb.The stem and cup are being added to the complaint.No part/lot information has been provided.The complaint was updated on: 3/3/2016.
 
Manufacturer Narrative
No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot codes were not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
Event Description
Ppf alleges pseudotumor and metal wear.Pfs alleges leg pain, weakness, tingling and inflammation, ringing of the ears, twitching of the eyes, tiredness, fluid collection, confusion, hair loss, trouble sleeping.
 
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.Udi:(b)(4).
 
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
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> 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, post market surveillance, 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.Device history lot
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> null.Device history batch
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> null.Device history review
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> null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Pfs alleges metal allergy, goiter, thyroid issues and inability to grow nails after clipping.After review of medical records, the patient was revised to address metallosis.Copious amounts of rust colored metallosis fluid was encountered, extensive amounts of metal stained tissue and necrotic tissue.There was no corrosion on the trunnion.When the hip was taken through a range of motion test, the femoral neck and posterior lip of the cup impinged.The stem was noted to be well fixed.The cup, however, was exceedingly anteverted.Clinical notes indicate discomfort, muscle shortening, clicking, edema, cysts and pre-revision limb asymmetry.Of note, a dislocation event occurred post-operatively during the patient's index surgery.A closed reduction was done immediately afterwards.Doi: (b)(6) 2006 - dor: (b)(6)2015 (right hip).
 
Manufacturer Narrative
Product complaint # (b)(4).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: added b5, b6 and h6 (patient codes).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H6 patient code: no code available (3191) used to capture the patient code joint contracture and limb asymmetry.
 
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Brand Name
UNKNOWN DEPUY FEMORAL STEM
Type of Device
HIP FEMORAL STEM/SLEEVE
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key5476381
MDR Text Key39549938
Report Number1818910-2016-14547
Device Sequence Number1
Product Code KXA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK-HIP
Was Device Available for Evaluation? No
Date Manufacturer Received12/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age48 YR
Patient Weight64
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