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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 32MM ATTUNE IMPLANT : KNEE PATELLA

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DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 32MM ATTUNE IMPLANT : KNEE PATELLA Back to Search Results
Model Number 1518-20-032
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Event Type  Injury  
Event Description
Medical records task received. After review of the medical records, office notes post revision reported pain, swelling, patella clunk and instability post revision. Treatment includes oral pain medication and physical therapy. Doi: (b)(6) 2020, doe: unknown, right knee.
 
Manufacturer Narrative
Product complaint # (b)(4). Occupation: lawyer. 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 MEDIAL DOME PAT 32MM
Type of DeviceATTUNE IMPLANT : KNEE PATELLA
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12838192
MDR Text Key280972070
Report Number1818910-2021-25623
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 Other,Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2022
Device Model Number1518-20-032
Device Catalogue Number151820032
Device Lot Number8534653
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/11/2017
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: 11/18/2021 Patient Sequence Number: 1
Treatment
ATTUNE MEDIAL DOME PAT 32MM; ATTUNE PS FEM RT SZ 5 CEM; ATTUNE PS RP INSRT SZ 5 8MM; ATUN TIB SLV M/L 29MM FULL POR; ATUNE PRESSFIT STR STEM14X60MM; ATUNE REV RP TIB BASE SZ 3 CEM; UNKNOWN BONE CEMENT
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