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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA/OV/DOME PAT 3PEG,38; SIGMA KNEE PRIMARY : KNEE PATELLA

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DEPUY ORTHOPAEDICS INC US PFC*SIGMA/OV/DOME PAT 3PEG,38; SIGMA KNEE PRIMARY : KNEE PATELLA Back to Search Results
Catalog Number 960102
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pulmonary Embolism (1498)
Event Date 10/27/2023
Event Type  Death  
Manufacturer Narrative
Product complaint # (b)(4).There is limited information regarding the patient's death at this time.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary, no device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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).A manufacturing records evaluation (mre) was not performed.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
Subject id: 007-00334.Study no: dots.Clinical adverse event received for vascular pe.Event is serious and is considered severe.Event is possibly related to procedure.Event is not related to device.Date of implant: (b)(6) 2009.Date of revision: (b)(6) 2023.Date of event: (b)(6) 2023.(right knee).Treatment: adverse event resulted in death.
 
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Type of Device
SIGMA KNEE PRIMARY : KNEE PATELLA
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
CORK MFG & MATERIAL WAREHOUSE
loughbeg ringaskiddy
cork
EI  
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key18138896
MDR Text Key328161715
Report Number1818910-2023-23218
Device Sequence Number1
Product Code JWH
UDI-Device Identifier10603295232629
UDI-Public10603295232629
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 Study,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/12/2013
Device Catalogue Number960102
Device Lot Number2782259
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/02/2023
Initial Date FDA Received11/15/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/19/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
BIOMET FEMORAL COMPONENT.; BIOMET TIBIAL BASE.; BIOMET TIBIAL INSERT.; DEPUY/CMW 2G.; DEPUY1 GENTAMICIN CEMENT 40G.; DEPUY1 GENTAMICIN CEMENT 40G.
Patient Outcome(s) Death;
Patient Age69 YR
Patient SexFemale
Patient Weight77 KG
Patient EthnicityHispanic
Patient RaceWhite
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