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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND 961610  ATTUNE MEDIAL DOME PAT 35MM; ATTUNE IMPLANT : KNEE PATELLA

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DEPUY IRELAND 961610  ATTUNE MEDIAL DOME PAT 35MM; ATTUNE IMPLANT : KNEE PATELLA Back to Search Results
Catalog Number 151820035
Device Problem Insufficient Information (3190)
Patient Problems Tissue Damage (2104); Not Applicable (3189)
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
Der states that patient got knee on (b)(6) 2017, shortly after tore quad tendon and got repaired.Doi: (b)(6) 2017.Dor: unknown; left knee.
 
Manufacturer Narrative
(b)(4).Investigation summary no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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 Name
ATTUNE MEDIAL DOME PAT 35MM
Type of Device
ATTUNE IMPLANT : KNEE PATELLA
Manufacturer (Section D)
DEPUY IRELAND 961610 
loughbeg ringaskiddy
cork
EI 
Manufacturer (Section G)
DEPUY IRELAND 961610 
loughbeg ringaskiddy
cork
EI  
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46582-0988
5743725905
MDR Report Key7618386
MDR Text Key111622222
Report Number1818910-2018-62624
Device Sequence Number1
Product Code JWH
UDI-Device Identifier10603295056683
UDI-Public10603295056683
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103756
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 05/21/2018
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 Expiration Date06/30/2022
Device Catalogue Number151820035
Device Lot Number8591130
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/21/2018
Initial Date FDA Received06/20/2018
Supplement Dates Manufacturer Received07/16/2018
Supplement Dates FDA Received07/20/2018
Date Device Manufactured08/09/2017
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 Age68 YR
Patient Weight100
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