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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL ANAT PAT 38MM ATTUNE IMPLANT : KNEE PATELLA

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DEPUY IRELAND - 9616671 ATTUNE MEDIAL ANAT PAT 38MM ATTUNE IMPLANT : KNEE PATELLA Back to Search Results
Model Number 1518-10-038
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Synovitis (2094); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/23/2020
Event Type  Injury  
Manufacturer Narrative

Product complaint #: (b)(4). Initial reporter occupation: lawyer. (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

It was reported that on (b)(6) 2017, the patient received a depuy right total knee replacement, to address osteoarthritis. The knee was a cemented tibial and femoral construct, with a fixed bearing insert. The patella was also resurfaced and two batches of depuy cement were used throughout. The surgeon reported that the procedure was tolerated well without any major complications. On (b)(6) 2020, the patient's right knee was revised to address pain, aseptic loosening of the tibial baseplate at the cement to implant interface, and medial collateral ligamentous instability. It was reported that the patient had experienced pain since his primary. All infection markers were negative, while a bone scan on (b)(6) 2019 showed tibial uptake, suggesting aseptic loosening of the tibial component. The patient also demonstrated on examination, that he had a significant amount of mid flexion instability, particularly with valgus stress, indicating laxity of the medial collateral ligament. Intraoperatively, surgeon noted that there was chronic appearing synovitis. The femoral component was well fixed, while the tibial tray was not well fixed to the cement mantle. The cement mantle, on the other hand, was itself well fixed to the bone. There was insufficiency of the medial collateral ligament requiring additional constraint. The patella was well-fixed and retained. All other depuy devices were revised and a constrained competitor revision knee system implanted. Intraoperative cultures were negative for evidence of infection. Date of implantation: (b)(6) 2017, date of revision: (b)(6) 2020, (right knee).

 
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Brand NameATTUNE MEDIAL ANAT PAT 38MM
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 Key11087941
MDR Text Key224079806
Report Number1818910-2020-27756
Device Sequence Number1
Product Code OIY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP830055
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 12/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1518-10-038
Device Catalogue Number151810038
Device LOT Number8498168
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 Received01/27/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/28/2017
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: 12/29/2020 Patient Sequence Number: 1
Treatment
ATTUNE CR FB INSRT SZ 5 8MM; ATTUNE CR FEM RT SZ 5 CEM; ATTUNE FB TIB BASE SZ 5 CEM; GHV BONE CEMENT 40 GRAMS; HV BONE CEMENT 40 GRAMS
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