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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 5 CEM ATTUNE IMPLANT : KNEE FEMORAL

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DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 5 CEM ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 1504-10-205
Device Problem Noise, Audible (3273)
Patient Problems Fatigue (1849); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Ambulation Difficulties (2544); Swelling/ Edema (4577)
Event Date 03/12/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Initial reporter occupation: lawyer. It is reasonable to conclude that the tibial insert is not the subject of ¿ and would not cause or contribute to, the reported serious injury of revision due to loosening of the tibial component at the implant to cement interface and/ or bone to cement interface or tibial component subsidence. It is also reasonable to attribute the patient¿s pain limp, difficulty ambulating, swelling, weakness of the leg and limited range of motion to the loosening and scarring. It was noted that scar material was on the extensor mechanism - this scarring is related to the extensor mechanism only and therefore only the femur and patella are coded and reported for scarring as they make up the extensor mechanism. The lateral tilt of the patella is can be assumed to have been caused by the scarring on the extensor mechanism - no indication the patella was mispositioned. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Attune medical records received. After review of the medical records the patient was revised to address aseptic loosening of prosthetic of the tibial component, a failed prosthesis with unilateral primary osteoarthritis resulting to chronic pain. Clinical visit showed pretibial soft tissue thickening at about the level of the mid shaft, scattered dystrophic calcification within the soft tissues, pruritis, erythema, weakness right leg, discomfort, residual neurologic deficit in her right leg, soft tissue swelling, tenderness, edema, impaired balance, gait and limited adl. No operative note provided. Doi: (b)(6) 2017. Dor: (b)(6) 2020, right knee.
 
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Brand NameATTUNE PS FEM RT SZ 5 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 Key12839348
MDR Text Key281008747
Report Number1818910-2021-25636
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,Consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/28/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received11/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1504-10-205
Device Catalogue Number150410205
Device Lot Number8449007
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/10/2017
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: 11/18/2021 Patient Sequence Number: 1
Treatment
ATTUNE MEDIAL DOME PAT 32MM; ATTUNE PS FEM RT SZ 5 CEM; ATTUNE PS RP INSRT SZ 5 7MM; ATTUNE RP TIB BASE SZ 4 CEM; SMARTSET GHV GENTAMICIN 40G
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