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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 6IN AML SM STATURE 12.0MM; HIP FEMORAL STEM/SLEEVE

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DEPUY ORTHOPAEDICS INC US 6IN AML SM STATURE 12.0MM; HIP FEMORAL STEM/SLEEVE Back to Search Results
Catalog Number 155401121
Device Problems Corroded (1131); Degraded (1153); Metal Shedding Debris (1804); Appropriate Term/Code Not Available (3191)
Patient Problems Host-Tissue Reaction (1297); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Discomfort (2330); Arthralgia (2355); Joint Swelling (2356); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Event Date 02/05/2018
Event Type  Injury  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is the subject of litigation or a legal claim and complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
 
Event Description
Litigation papers allege corrosion and friction wear is believed to have caused amounts of toxic cobalt-chromium metal ions and particles to be released into the patient's tissue surrounding the implants.As a result, the patient has been experiencing severe pain and difficulty with her implants.The patient has experienced severe pain and discomfort and inflammation in both of her thigh and hip areas.She also feels extreme discomfort when walking.Blood testing indicated that the patient's cobalt and chromium levels are elevated.She is expected to undergo revision surgeries to remove the devices in both hips.
 
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.
 
Manufacturer Narrative
(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
 
Event Description
Update 4/15/16- pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Pfs reported pain, decreased mobility, weakness, difficulty walking and standing, walk with limp, swelling, elevated metal ions, unable to do activities of daily living and constant headaches for 9 months.Medical records reported bilateral crepitus, decreased mobility, difficulty sleeping, grinding, joint pain, limping, locking, popping, stiffness, tenderness and weakness with right greater than left.Metal ion lab results reported chromium greater than 7 parts per billion.No revision surgical report or report of revision surgery completed.Mars mri reported fluid collection consistent with alval.Part/lot updated.The complaint was updated on: may 4, 2016.
 
Manufacturer Narrative
Examination of the reported devices was not possible as they were not returned.A search of the complaints databases identified other reports against the femoral head and/or liner.Per procedure, this device(s) is exempt from device history record review.A search of the complaints databases identified no other reports against the remaining product/lot code combinations.Medical records were reviewed.The investigation can draw no conclusions with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Ppf alleges metallosis.
 
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.  .
 
Event Description
After review of medical records, patient was revised due to failed hip arthroplasty.Operative findings indicated metallosis, soft tissue destruction and trunionosis.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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, 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
6IN AML SM STATURE 12.0MM
Type of Device
HIP FEMORAL STEM/SLEEVE
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key5380466
MDR Text Key36419680
Report Number1818910-2016-11315
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
PK061833
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Catalogue Number155401121
Device Lot NumberDP3EHA000
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/15/2016
Initial Date FDA Received01/20/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
01/21/2019
04/02/2019
12/11/2019
Supplement Dates FDA Received03/16/2016
05/04/2016
06/16/2016
01/23/2019
04/22/2019
01/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age73 YR
Patient Weight61
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