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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 7 6MM ATTUNE IMPLANT : KNEE TIBIAL INSERT

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DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 7 6MM ATTUNE IMPLANT : KNEE TIBIAL INSERT Back to Search Results
Model Number 1516-40-706
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Synovitis (2094)
Event Date 11/05/2020
Event Type  Injury  
Manufacturer Narrative
(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 the (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) on (b)(6) 2018 for past 3 days has medial l knee pain, different than djd pain. Had cabg 11/8 at (b)(6) and apparently had dehiscence of wound for vein harvesting l knee. Had i and d done late nov 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 PS FB INSRT SZ 7 6MM
Type of DeviceATTUNE IMPLANT : KNEE TIBIAL INSERT
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 46581-0988
6107428552
MDR Report Key12505850
MDR Text Key272463803
Report Number1818910-2021-20608
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111433
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? No
Device Operator
Device Expiration Date05/31/2018
Device Model Number1516-40-706
Device Catalogue Number151640706
Device Lot Number382807
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 Received10/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/22/2013
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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