MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE PATELLA

Catalog Number UNK KNEE PATELLA

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Muscular Rigidity (1968); Pain (1994); Pneumonia (2011); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 02/26/2022

Event Type  Injury  

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: maheshwari av, garnett ct, cheng th, buksbaum jr, singh v, shah nv.Does resident participation influence surgical time and clinical outcomes? an analysis on primary bilateral single-staged sequential total knee arthroplasty.Arthroplast today.2022 apr 8;15:202-209.E4.Doi: 10.1016/j.Artd.2022.02.029.Pmid: 35774880; pmcid: pmc9237261.Objective and methods: fifty patients who underwent single-staged bilateral total knee replacements (tka) were evaluated for impacts contributed to procedures by the performance of chief surgical resident participation.In all cases, the attending surgeon performed the first of the two bilateral tkas, with the chief 5th year resident performing the second knee replacement with assistance by the attending.Depuy pfc sigma ps cemented knees were implanted in 29 patients (58 knees), depuy attune ps, cemented knees were implanted in 19 patients (38 knees), and two different competitor knee systems were implanted in two patients (4 knees).These were compared against a control group of four patients receiving single-staged bilateral total knee replacements by the attending only.Specific patient data by case and product information by case was not provided.Results: there were no intraoperative complications.Blood loss was greater on the resident side versus the attending side, but nothing that was abnormal or that warranted treatment.There were 7 post-operative complications as follows (# instances, diagnosis, treatment): 1: aspiration pneumonitis after general anesthesia, treated inpatient with antibiotics, pulmonary hygiene, and incentive spirometry, resolved uneventfully.1: peroneal deep vein thrombosis (dvt), identified inpatient, treated with aspirin and monitored over 8 weeks with serial clinical examination and doppler ultrasound, resolved uneventfully.1: patient expired at 6 weeks post operation, at a different emergency room, following an initial uneventful course.Patient had comorbidities of bmi of 30 kg/m2, hypertension¿and was still on aspirin for venous thromboembolism prophylaxis.No post-mortem analysis or pe studies were performed, but a cardiopulmonary cause was suspected per emergency room notes.1: complex regional pain syndrome (crps), identified post-op in hospital and resumed after discharge, being treated conservatively by pain management consultation, unresolved.1: patellar clunk, identified at 1 year follow-up, and treated with surgical excision at 15 months post-op, resolved uneventfully.2: stiffness, identified at 6 weeks in one patient, 3 months in the other, treated with manipulation of the knee under anesthesia for both.

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.Device history lot - a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNKNOWN KNEE PATELLA
• Type of Device: KNEE PATELLA
• 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: 15754317
• MDR Text Key: 303259851
• Report Number: 1818910-2022-22423
• 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,Followup
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE PATELLA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2022
• 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