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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK KNEE FEMORAL ATTUNE PS; FEMORAL 
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DEPUY IRELAND - 9616671 UNK KNEE FEMORAL ATTUNE PS; FEMORAL  Back to Search Results
Catalog Number UNK KNEE FEMORAL ATTUNE PS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 03/15/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint # (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
The patient was revised to address pain.Patient presented with a sz 6 left attune ps femur with an attune revision tibia.Tibial side was well fixed and not revised.Doctor removed the sz 6 femur, which was cemented and well fixed.The poly removed was 6x14mm rp attune revision poly.Doctor then revised the femur with a 6 attune revision femur, 40mm femoral sleeve and a 12x60mm stem.No lot numbers were able to be visualized due to cement on the femur.All information that the doctors office has been provided.All information that was obtained from the revision surgery were provided.Original implant date is unknown.No loosening and no delay on surgery.Doi: unk.Dor: (b)(6) 2021; left knee.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
 
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Brand Name
UNK KNEE FEMORAL ATTUNE PS
Type of Device
FEMORAL 
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11596600
MDR Text Key243183548
Report Number1818910-2021-06656
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK KNEE FEMORAL ATTUNE PS
Was Device Available for Evaluation? No
Date Manufacturer Received04/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
6X14MM RP ATTUNE REVISION POLY; BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN); SZ 6 LEFT ATTUNE PS FEMUR; UNK KNEE TIBIAL TRAY ATTUNE REVISION; 6X14MM RP ATTUNE REVISION POLY; BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN); SZ 6 LEFT ATTUNE PS FEMUR; UNK KNEE TIBIAL TRAY ATTUNE REVISION
Patient Outcome(s) Required Intervention;
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