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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. UNKNOWN DEPUY SIGMA MBT KEEL TIBIAL TRAY; KNEE TIBIAL TRAY

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DEPUY ORTHOPAEDICS, INC. UNKNOWN DEPUY SIGMA MBT KEEL TIBIAL TRAY; KNEE TIBIAL TRAY Back to Search Results
Catalog Number UNK-KNEE
Device Problem Loss of or Failure to Bond (1068)
Patient Problem Discomfort (2330)
Event Date 11/10/2008
Event Type  Injury  
Event Description
Legal claim and medical records received.Patient was revised on (b)(6) 2008 for anterior-posterior instability, loose tibial component, and discomfort.The patella and femoral component were found to be stable.It is reasonable to conclude the instability and discomfort are a result of the loosening.There were also two cysts found.The loosening interface and cement manufacture is unknown at this time.
 
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 still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.Udi: unavailable.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 filled as appropriate.
 
Manufacturer Narrative
Additional narrative: the device associated with this report was not returned.Review of the device history records and/or a lot specific complaint database search was not possible as the product and lot code required was not provided.Medical records were reviewed and with the information provided it cannot be determined that the complaint is product related.The ifu cautions that obesity tends to impose severe loading on the affected extremity thereby placing the patient at higher risk of failure of the knee replacement.It is not known to what extent this and other comorbidities contributed to the reported event.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not 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
Additional narrative: conclusion and justification status for mdr: update 1/23/2015 & 2/3/2015-med recs received.Patient medical records were received and reviewed by a depuy medical professional.The exact root cause of the reported patient condition is unknown.The patient has comorbidities that affect the bone strength and healing and multiple medications that are known to affect the bone and cause pain.It is documented the patient to have bone quality that appeared to be somewhat soft.In a care note, it was reported that the surgeon wants the patient to see her neurosurgeon to evaluate the possibility that the source of her leg pains is lumbar radiculopathy.The patient self-reported several falls over the years could have affected her right total knee arthroplasty.From a medical perspective, based on the information available to be reviewed, the complaint is unlikely to be product related.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not 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.
 
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Brand Name
UNKNOWN DEPUY SIGMA MBT KEEL TIBIAL TRAY
Type of Device
KNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
steve dowell
700 orthopaedic drive
warsaw, IN 46581
5743714918
MDR Report Key4267668
MDR Text Key15805633
Report Number1818910-2014-32205
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Attorney
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 10/22/2014
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 NumberUNK-KNEE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/08/2015
Initial Date FDA Received11/20/2014
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received02/14/2015
07/10/2015
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 Number1
Patient Outcome(s) Required Intervention;
Patient Age54 YR
Patient Weight83
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