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

Catalog Number UNK KNEE FEMORAL LCS

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

Patient Problems Pulmonary Embolism (1498); Unspecified Infection (1930); Muscular Rigidity (1968); Thrombosis/Thrombus (4440)

Event Date 04/01/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint#: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: gibbons jp, cassidy rs, bryce l, napier rj, bloch bv, beverland de.Is cementless total knee arthroplasty safe in women over 75 y of age? j arthroplasty.2023 apr;38(4):691-699.Doi: 10.1016/j.Arth.2022.10.021.Epub 2022 oct 19.Pmid: 36272510.Objective and methods: background: cementless total knee arthroplasty (tka) is the subject of renewed interest.Previous concerns about survivorship have been addressed and there is an appeal in terms of biological fixation and surgical efficiency.However, even surgeon advocates have concerns about the risk of marked subsidence when using this technology in older patients at risk for osteoporosis.Methods: this was a retrospective analysis of 1,000 consecutive fully cementless mobile bearing lcs complete rp tkas implanted between july 1, 2009 and february 28, 2019 on women over 75 years of age who had postoperative and 1-year x-rays.No patellas were resurfaced.The primary outcome was the incidence of subsidence.Results: there were three asymptomatic cases with definite subsidence and change in alignment.In a fourth symptomatic case, the femoral component subsided into varus and the tibia into valgus, thus maintaining alignment which facilitated nonoperative treatment in a 92-year-old.Overall, at 1 year, there were two- liner revisions for infection without recurrence.Five patients had further surgery, of which three were washouts and two were for periprosthetic fractures sustained postoperatively within 1 year.Seven patients had further anesthesia, of which five were manipulations and two were nonrecurrent closed reductions for spinouts.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: cementless lcs complete rp tka including femoral component, tibial tray, and tibial insert.Adverse event(s) and provided interventions associated with depuy devices: radiographic results without identified treatment: 3 reports of radiolucent lines with tibial subsidence- no treatment provided non-patient specific results: 3 revisions of the liner to treat infection 5 muas to treat stiffness 2 closed reductions to treat spin-out 2 dvts- treatment unknown 17 pulmonary embolisms- treatment unknown patient specific results: fig.4: 92-year-old female patient with tibial and femoral subsidence identified on day 15, causing varus/valgus misalignment.Treated with a knee brace and non-weightbearing.Fig.5: female patient reported pain at 11 days post-op.Radiographs identified a periprosthetic femoral fracture and notching.Treated with orif.Fig.6: female patient with pain and femoral fracture secondary to a fall 61 days post-implantation.Treated with orif.

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.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot : the device lot number is unknown, therefore a device history review could not be performed.  if the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: UNK KNEE FEMORAL LCS
• Type of Device: FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18044490
• MDR Text Key: 327019113
• Report Number: 1818910-2023-22113
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/31/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE FEMORAL LCS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 10/31/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 11/03/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention