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

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.

• 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 Key: 4267668
• MDR Text Key: 15805633
• Report Number: 1818910-2014-32205
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Number: UNK-KNEE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/08/2015
• Initial Date FDA Received: 11/20/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/14/2015; 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 Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 83