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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 Adhesion(s) (1695); Fall (1848); Pain (1994); Joint Laxity (4526)
Event Date 01/04/2019
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
Initial report: the patient was revised to address loosening of the tibial and femoral components at the bone to cement interface. Cement manufacturer is unknown. Revised patient's knee subsequent to a fall. The trauma caused proximal tibia fracture and instability. Doi: unknown. Dor: (b)(6) 2019. Right knee. Medical records received and provide the following information: primary operative notes (b)(6) 2015 indicate the patient received a right total knee replacement due to end stage osteoarthritis. The patella was resurfaced, and depuy cement was utilized x2. The surgery was completed without indication of complication by the surgeon. Revision operative notes (b)(6) 2019 indicate the patient received a right total knee revision due to pain and subsidence of the tibial and femoral components. Notes indicate the patient was experiencing pain prior to a recent fall but the pain increased significantly post fall and led her to be seen by her doctor. Upon entering the joint, significant adhesions were encountered and removed. Tibia and femoral components were noted to be loose and revised along with the insert. Patella remained implanted with no indication of deficiency. The surgery was completed without indication of complication by the surgeon.
 
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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)
CORK MFG & MATERIAL WAREHOUSE
loughbeg ringaskiddy
cork
EI
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581
6107428552
MDR Report Key11848994
MDR Text Key251439834
Report Number1818910-2021-10646
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2021
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 Number8060099
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/03/2015
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: 05/19/2021 Patient Sequence Number: 1
Treatment
ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS RP INSRT SZ6 5MM; ATTUNE RP TIB BASE SZ 5 CEM; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G
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