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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE TIBIAL TRAY

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DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE TIBIAL TRAY Back to Search Results
Catalog Number UNK KNEE TIBIAL TRAY
Device Problem Loss of or Failure to Bond (1068)
Patient Problem Foreign Body Reaction (1868)
Event Date 12/04/2023
Event Type  Injury  
Manufacturer Narrative
Product complaint#: (b)(4).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
Attune primary revised for tibial loosening after 4 years of implantation.Tibial tray lifted out of patient.Backside of tray completely clean.Score marks on underside of poly implying backside wear.Grey coloured membrane tissues removed from patient indicate possible metallosis.
 
Manufacturer Narrative
Product complaint # (b)(4).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.
 
Event Description
Additional information was received and states that there was a loosening between the underside of the tray and the surface of the prepared tibia.
 
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Brand Name
UNKNOWN KNEE TIBIAL TRAY
Type of Device
KNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581
3035526892
MDR Report Key18307665
MDR Text Key330226832
Report Number1818910-2023-25132
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/11/2023
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? Yes
Device Operator Health Professional
Device Catalogue NumberUNK KNEE TIBIAL TRAY
Device Lot Number8636226
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/04/2023
Initial Date FDA Received12/11/2023
Supplement Dates Manufacturer Received12/21/2023
Supplement Dates FDA Received01/03/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/08/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
ATTUNE PS FEM RT SZ 6 CEM.; UNKNOWN KNEE TIBIAL INSERT.
Patient Outcome(s) Required Intervention;
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