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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 41MM ATTUNE IMPLANT : KNEE PATELLA

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DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 41MM ATTUNE IMPLANT : KNEE PATELLA Back to Search Results
Model Number 1518-20-041
Device Problems Loss of or Failure to Bond (1068); Use of Device Problem (1670)
Patient Problems Pain (1994); Synovitis (2094)
Event Date 11/05/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Claim and medical records received. On (b)(6) 2014, the patient had a left total knee arthroplasty to address end-stage osteoarthritis. Depuy components were implanted during this procedure, including depuy patella including depuy cement x2. (part/lot page 10,11 of 58). (b)(6) 2018 for past 3 days has medial l knee pain, different than djd pain. Had cabg (b)(6) at (b)(6) and apparently had dehiscence of wound for vein harvesting l knee. Had i and d done late (b)(6) at post op f/u. Knee was aspirated to determine if there is an infection. It was not infected. On (b)(6) 2020, the patient had a revision, the findings from the surgery included loose tibia, and patella, femur was well fixed, and there was extensive synovitis and pain. The femoral component was slightly externally rotated. The patella button was malpositioned and appeared loose. There was proximal tibial bone loss noted. Competitor cement was used during this procedure. Doi: (b)(6) 2014, dor: (b)(6) 2020, unk knee.
 
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Brand NameATTUNE MEDIAL DOME PAT 41MM
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 Key12505846
MDR Text Key272463602
Report Number1818910-2021-20607
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 consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2019
Device Model Number1518-20-041
Device Catalogue Number151820041
Device Lot Number7846115
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/17/2014
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: 09/21/2021 Patient Sequence Number: 1
Treatment
ATTUNE FB TIB BASE SZ 7 CEM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FB INSRT SZ 7 6MM; ATTUNE PS FEM LT SZ 7 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
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