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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 6 CEM ATTUNE IMPLANT : KNEE FEMORAL

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DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 6 CEM ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 1504-10-206
Device Problem Migration (4003)
Patient Problems Necrosis (1971); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/10/2021
Event Type  Injury  
Manufacturer Narrative
(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
Patient had an attune tkr put in on the (b)(6) 2021. Patient reported ongoing pain post operatively and was reviewed once by her gp and was referred back to surgeon last month. Upon further investigation, it was observed that there was medial collapse of her distal femoral condyle. Surgeon suspects she developed avn on that side of her femur which caused the collapse of the bone and subsequent implant failure. Patient underwent a revision tkr today and was revised to an attune revision implant. Palacos cement was used in the first operation and again in the revision today.
 
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Brand NameATTUNE PS FEM RT SZ 6 CEM
Type of DeviceATTUNE IMPLANT : KNEE FEMORAL
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 Key12373831
MDR Text Key268346190
Report Number1818910-2021-18771
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P830055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1504-10-206
Device Catalogue Number150410206
Device Lot Number9481597
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/15/2020
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: 08/26/2021 Patient Sequence Number: 1
Treatment
ATTUNE PS FEM RT SZ 6 CEM; ATTUNE PS RP INSRT SZ 6 7MM; ATTUNE RP TIB BASE SZ 6 CEM; COMPETITOR CEMENT - PALACOS
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