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

Catalog Number UNK KNEE FEMORAL SIGMA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Unspecified Musculoskeletal problem (4535); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Article entitled ¿metal hypersensitivity and complex regional pain syndrome after bilateral total knee arthroplasty¿ written by navraj s.Sagoo, md, ruhi sharma, bs, sami alaraj, bs, ishaan k.Sharma, bs, adam j.Bruntz, pa-c, and gurpreet s.Bajaj, md published in the journal of bone and joint surgery in 2021 was reviewed.The purpose of the article was to present a rare case of metal hypersensitivity after bilateral tka in a patient who subsequently suffered from complex regional pain syndrome (crps).38-year-old male underwent bilateral tkas in 2011 with pfc sigma rp.No mention of patella resurfacing.Medical history: obesity and bilateral tibial tubercle osteotomies with titanium screw fixation for painful, chronic patellofemoral chondromalacia.Adverse events: 2 months, the patient developed new-onset of pain and stiffness in bilateral knees.On physical examination, severe crepitus and edema were evident in both knees and the passive range of motion of both knees became progressively more limited.In addition, atrophy and weakness of bilateral quadriceps were noted despite aggressive physical therapy.Infection work up was negative.Radiographs of bilateral knees showed appropriate position and fixation of implants.Technetium-99m bone scintigraphy was performed, revealing mildly increased periprosthetic uptake near bilateral implants, suggesting an inflammatory process of the synovial lining of both knees.The suspected synovitis noted on bone scintigraphy and symptoms of quadriceps weakness led to suspicion of poor tolerance of the rp constructs, and the patient underwent revision of bilateral rotating tibial components to fixed-bearing constructs.The synopsis of physical examination findings and his extensive surgical history led to consideration of crps.With this in mind, the patient underwent a series of lumbar sympathetic ganglion blocks followed by the implantation of a spinal cord stimulator to which the patient temporarily responded with improved mobilization and joint function.However, around 10 months after the primary implantation of bilateral tkas, the patient reported progression of pain into his upper extremities, now with significant swelling, erythema, and burning sensations in all 4 extremities.Furthermore, the patient developed what appeared to be distinct eczematous lesions around his lateral side of the right knee.The plaque-like lesions, which had no raised edges nor were pruritic in nature, had progressed over 4 months to his both inner thighs and genitalia.Consults to rheumatology, infectious disease, and endocrinology revealed no abnormal findings.Considering a skin allergy, the patient also underwent dermal patch testing which elicited no reaction to cobalt, chromium, nickel, titanium, or polyethylene.With a tentative diagnosis of nickel hypersensitivity, the patient elected to proceed with a 2-stage bilateral tka revision with hypoallergenic, oxidized zirconium alloys.Intraoperatively, there were significant hyperplasia and hyperemia of the synovial tissues.The implants were well-fixed.During the immediate postoperative course, the patient experienced a significant reduction in swelling with a net loss of nearly 7 l of fluid over a 3-day period.Findings of increased mobility and joint function were additionally noted along with complete resolution of his eczema.

Manufacturer Narrative

Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.(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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNK KNEE FEMORAL SIGMA
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15758989
• MDR Text Key: 303309498
• Report Number: 1818910-2022-22498
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE FEMORAL SIGMA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2022
• 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