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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 5 CEM; ATTUNE IMPLANT : KNEE FEMORAL

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DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 5 CEM; ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Catalog Number 150410205
Device Problem Loss of or Failure to Bond (1068)
Patient Problems Pain (1994); Not Applicable (3189)
Event Date 07/11/2017
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.
 
Event Description
Reviewed medical records received on 14 may 2018.Records indicated patient received attune total knee replacements in both knees, utilizing competitor bone cement in both cases.The right knee was revised to address progressive pain and unspecified deformity of the knee, with aseptic implant loosening reported at both implant to cement interfaces of the femur and the tibia base plate components.Revising surgeon reported both femur and tibia were grossly loose in findings.He reported that the femur came loose from its cement mantle with instrument assistance.He stated that the tibia implant came out by hand, with no cement adhered to the tibia component.Cement mantles for both products were removed with more land instruments.The patella component was well-fixed and was not revised.With the exception of the patella, surgeon re-implanted competitor products.Doi: (b)(6) 2014; dor: (b)(6) 2017; (right knee).
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Device history lot: null.Device history batch: null.Device history review: null.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.
 
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Brand Name
ATTUNE PS FEM RT SZ 5 CEM
Type of Device
ATTUNE IMPLANT : KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork, munster
EI 
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46582-0988
5743725905
MDR Report Key7553919
MDR Text Key109560070
Report Number1818910-2018-60884
Device Sequence Number1
Product Code NJL
UDI-Device Identifier10603295041764
UDI-Public10603295041764
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P830055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/14/2018
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 Health Professional
Device Catalogue Number150410205
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/14/2018
Initial Date FDA Received05/30/2018
Supplement Dates Manufacturer Received07/10/2018
Supplement Dates FDA Received07/16/2018
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 Age62 YR
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