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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK KNEE FEMORAL LCS; FEMORAL 

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DEPUY ORTHOPAEDICS INC US UNK KNEE FEMORAL LCS; FEMORAL  Back to Search Results
Catalog Number UNK KNEE FEMORAL LCS
Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)
Patient Problems Ossification (1428); Adhesion(s) (1695); Cyst(s) (1800); Foreign Body Reaction (1868); Unspecified Infection (1930); Muscular Rigidity (1968); Pain (1994); Joint Laxity (4526); Unspecified Musculoskeletal problem (4535)
Event Date 01/01/2019
Event Type  Injury  
Event Description
Article entitled ¿the effect of implant modification the low contact stress experience¿ written by a.Pineda, m.B.Pabbruwe, a.M.Kop, p.Vlaskovsky, and m.Hurworth published in the bone and joint journal science direct in 2019 as reviewed.The aim of this study was to conduct the largest low contact stress (lcs) retrieval study to elucidate the failure mechanisms of the porocoat and duofix femoral component.The latter design was voluntarily recalled by the manufacturer.The study included 104 revised uncemented lcs implants which were analyzed.Patients were either implanted with porocoat implants for duofix implants.Adverse events (based off the aes provided patients experienced more than one adverse event and the data is summarized) reason for removal/observation at removal adverse event(s) possibly associated with unk lcs femoral component 104 device revision and replacements 67 for pain 27 for implant loosening (bone to implant) 29 for joint instability 10 for infection 14 for implant mispositioning 9 for joint stiffness 8 for metallosis 33 for debris tissue staining 26 for bone reabsorption 53 for scar tissue 3 for heterotopic ossification 8 for effusion/cyst adverse event(s) possibly associated with unk lcs tibial component 104 device revision and replacements 67 for pain 27 for implant loosening (bone to implant) 29 for joint instability 10 for infection 14 for implant mispositioning 9 for joint stiffness 8 for metallosis 33 for debris tissue staining 26 for bone reabsorption 53 for scar tissue 3 for heterotopic ossification 8 for effusion/cyst adverse event(s) possibly associated with unk lcs tibial insert 104 device revision and replacements 67 for pain 29 for joint instability 10 for infection 9 for joint stiffness 8 for metallosis 23 for osteolysis 33 for debris tissue staining 26 for bone reabsorption 53 for scar tissue 3 for heterotopic ossification 8 for effusion/cyst.
 
Manufacturer Narrative
Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.The size of the article is too large to attach/submit with the 3500a submission.The citation of the article has been provided below: ¿the effect of implant modification the low contact stress experience¿ written by a.Pineda, m.B.Pabbruwe, a.M.Kop, p.Vlaskovsky, and m.Hurworth published in the bone and joint journal science direct in 2019 as reviewed.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.
 
Manufacturer Narrative
Product complaint#: (b)(4).Investigation summary: no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.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 device lot number is unknown, therefore a¿device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.
 
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Brand Name
UNK KNEE FEMORAL LCS
Type of Device
FEMORAL 
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 46581-0988
3035526892
MDR Report Key19132379
MDR Text Key340450293
Report Number1818910-2024-08557
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/18/2024
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 Catalogue NumberUNK KNEE FEMORAL LCS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/26/2024
Initial Date FDA Received04/18/2024
Supplement Dates Manufacturer Received04/18/2024
Supplement Dates FDA Received04/23/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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