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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE PS FEM LT SZ 10 CEM ATTUNE IMPLANT : KNEE FEMORAL

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DEPUY ORTHOPAEDICS INC US ATTUNE PS FEM LT SZ 10 CEM ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 1504-10-110
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/28/2021
Event Type  malfunction  
Event Description
It was reported that foam in manufacturing package was stuck to condyle surface when opened so implant was discarded.
 
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.
 
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Brand NameATTUNE PS FEM LT SZ 10 CEM
Type of DeviceATTUNE IMPLANT : KNEE FEMORAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12823610
MDR Text Key281020086
Report Number1818910-2021-25253
Device Sequence Number1
Product Code OIY
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 Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1504-10-110
Device Catalogue Number150410110
Device Lot Number403288
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/17/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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