MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK KNEE TIBIAL INSERT SIGMA

Catalog Number UNK KNEE TIBIAL INSERT SIGMA

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

Patient Problems Wound Dehiscence (1154); Adhesion(s) (1695); Bone Fracture(s) (1870); Hematoma (1884); Unspecified Infection (1930); Post Operative Wound Infection (2446); Thrombosis/Thrombus (4440); Joint Laxity (4526); Unspecified Tissue Injury (4559)

Event Date 01/15/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.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

Article entitled ¿unicompartmental knee arthroplasty vs total knee arthroplasty for medial compartment arthritis in patients older than 75 years: comparable reoperation, revision, and complication rates¿ written by homayoun siman, md, atul f.Kamath, md, nazly carrillo, md, william s.Harmsen, ms, mark w.Pagnano, md, and rafael j.Sierra, md published in the journal of arthoplasty on january 15, 2017 was reviewed.The aim of our study was to answer three questions - in patients aged 75 and older who have radiographic imaging consistent only with medial compartment arthritis undergoing either tka or uka, (1) ¿what are the complications associated with each procedure?¿ (2) ¿what are the reasons for implant revision?¿ and (3) ¿what are the clinical results and is there a difference in implant survivorship at midterm follow-up?¿ 188 knees were included in the tka group and 114 were implanted with the depuy sigma knee.The remaining patients had competitor products.120 knees were included within the uka and none of the knees were implanted with depuy implants.No mention of cement mfg or if the patella was resurfaced.Adverse events related to the tka cohort (not specific to the depuy sigma knee): 1 knee with deep venous thrombosis ¿ treatment not indicated.4 knees with cardiovascular adverse events ¿ treatment not indicated.2 knees with bone fractures ¿ location of fractures and treatment not indicated.1 knee with wound dehiscence.3 knees with superficial infections ¿ treatment not indicated.2 knees with hematomas ¿ treatment not indicated.3 knees with tendon/ligament damage ¿ treatment not indicated.1 knee with instability ¿ treatment not indicated.1 knee revision for implant loosening ¿ both components revised.1 knee required i&d with poly exchange for deep infection.2 knees with bone fractures requiring orif.2 knees requiring manipulation under anesthesia for arthrofibrosis.2 knees requiring arthroscopic debridement for patellar clunk syndrome.

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: UNK KNEE TIBIAL INSERT SIGMA
• Type of Device: KNEE TIBIAL INSERT
• 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: 15389567
• MDR Text Key: 299559023
• Report Number: 1818910-2022-17481
• Device Sequence Number: 1
• Product Code: NJL
• 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: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE TIBIAL INSERT SIGMA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2022
• 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