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

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.

• 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 Key: 15106177
• MDR Text Key: 296616950
• Report Number: 1818910-2022-14102
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Number: UNK 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 Received: 07/26/2022
• Supplement Dates Manufacturer Received: 08/24/2022
• Supplement Dates FDA Received: 08/25/2022
• 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 Number: 1
• Patient Outcome(s): Required Intervention