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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNK KNEE FEMORAL LPS; FEMORAL  Back to Search Results
Catalog Number UNK KNEE FEMORAL LPS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Hematoma (1884); Unspecified Tissue Injury (4559)
Event Date 07/08/2022
Event Type  Injury  
Event Description
Article entitled "emergency use of a custom distal femoral replacement system for acute periprosthetic fracture with catastrophic implant failure" written by ahmed k.Emara, md, mitchell ng, md, viktor e.Krebs, md, and nicolas s.Piuzzi, md published in the journal of bone and joint surgery on august 12, 2021 was reviewed.The purpose of the present study is to describe the emergent use of a custom dfr for the management of a patient with complex amc presenting with periprosthetic knee fracture and multiply revised tka and an ipsilateral tha.Study included a 57-year-old male with amc to underwent a left total tka with competitor products with patella resurfacing two prior revisions using unknown products.Depuy-synthes was ultimately placed after treatment for infection.A srom hinged knee was placed.He experienced modest improvement in range-of-motion and function but developed interprosthetic femoral stress fracture and underwent cortical strut placement.Five years later, he underwent further revision (unknown reason) of his tka using a depuy s-rom small femoral component followed by revision to the depuy resurfacing limb preservation system (lps)-hinge revision system (depuy) after 8 years for persistent pain and component loosening (unknown component, loosening interface, or cement mfg).He presented emergency department after a misstep on the stairs with audible crack and immediate severe left knee pain and inability to ambulate.The left lower extremity was neurovascularly intact but demonstrated large anterior swelling, tenderness, and external rotation deformity of the distal thigh with loss of active extension.Radiographs showed fracture of an uncovered stem-condylar junction and rotating hinge femoral component¿s failure in hyperextension with marked distal femoral bone deficiency.The medial parapatellar approach uncovered a torn, punctuated, thinned, and scarred extensor mechanism with the surrounding dark-stained tissue.Arthrotomy evacuated 500- ml hematoma and revealed underlying metallosis from the patient¿s jerky and hyperextension¿locking-dependent gait with subsequent excessive loading of the hinge mechanism.Extensor mechanism was redundant, scarred, nonmobile, and adherent to the joint capsule, requiring extensive quadricepsplasty and release of damaged quadriceps tendon from the suprapatellar region adverse events -1st revision ¿ interprosthetic femoral stress fracture and underwent cortical struct placement.-2nd revision - further revision (unknown reason) of his tka using a depuy s-rom small femoral component.3rd revision - depuy s-rom small femoral component revision for pain and component loosening - unknown component, loosening interface, or cement mfg.4th revision - fracture of an uncovered stem-condylar junction.Patient presented with audible crack and immediate severe left knee pain, swelling, tenderness, and inability to ambulate.The medial parapatellar approach uncovered a torn, punctuated, thinned, and scarred extensor mechanism with the surrounding dark-stained tissue.Arthrotomy evacuated 500- ml hematoma and revealed underlying metallosis.
 
Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.
 
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Brand Name
UNK KNEE FEMORAL LPS
Type of Device
FEMORAL 
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kate karberg
700 orthpaedic dr.
warsaw, IN 46581
3035526892
MDR Report Key15106177
MDR Text Key296616950
Report Number1818910-2022-14102
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/26/2022
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 FEMORAL LPS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/08/2022
Initial Date FDA Received07/26/2022
Supplement Dates Manufacturer Received08/24/2022
Supplement Dates FDA Received08/25/2022
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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