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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM RT SZ 7 CEM ATTUNE IMPLANT : KNEE FEMORAL

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DEPUY IRELAND - 9616671 ATTUNE CR FEM RT SZ 7 CEM ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 1504-00-207
Device Problem Loss of or Failure to Bond (1068)
Patient Problems Inflammation (1932); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 04/06/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Revision of an attune cr fb. Primary surgery was done in 2017. Primary surgeon unknown. Prior patient notes were unavailable. Radiographs unavailable. Male. Right side. The patient was progressively unhappy with the right side. Surgeon described seeing potential loosening on the x-ray on the lateral side of both the femur and tibia. The patella was unresurfaced, but the surgeon also noted that there may be issued with the patella position attributing to the pain. They also had elevated inflammatory markers in their blood potentially indicating a low grade infection. The patient has been experiencing pain during exercise on the right side, while having no issues at all on the left side. When we were about to remove the tibial insert we noticed that it wasn't locked into the tibial tray as it should be. As this has been loose it may have also attributed to the pain which the patient was experiencing. No adverse wear to the poly insert was observed. Either the inset wasn't impacted correctly in the first instance, or at some stage the poly liner has become unlocked from the tibial tray. When the femoral component was removed there appeared to be no difference in fixation between the medial and lateral sides. When the tibial tray implant was removed there was no cement fixation on the base of the tibial tray on the lateral posterior aspect of the implant. The surgeon also said that the tibial tray was easier to remove than the femur, but they weren't loosely fixed.
 
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Brand NameATTUNE CR FEM RT SZ 7 CEM
Type of DeviceATTUNE IMPLANT : KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581
6107428552
MDR Report Key11694709
MDR Text Key246318468
Report Number1818910-2021-08311
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
P830055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 04/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1504-00-207
Device Catalogue Number150400207
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2021
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 Treatment Data
Date Received: 04/20/2021 Patient Sequence Number: 1
Treatment
ATTUNE FB TIB BASE SZ 8 CEM; UNK ATTUNE KNEE TIBIAL INSERT
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