MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE TIBIAL TRAY

Catalog Number UNK KNEE TIBIAL TRAY

Device Problems Osseointegration Problem (3003); Migration (4003)

Patient Problems Pain (1994); Inadequate Osseointegration (2646)

Event Date 02/22/2022

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 ¿a short-term multicenter analysis of radiolucent lines in a single uncemented rotating platform implant for total knee arthroplasty¿ written by jason desmarais, david dalury, thomas l.Bernasek, david a.Fisher, ryan m.Nunley, marie-claire fickenscher, and robert s.Gorab published in arthroplasty today on february 22, 2022 was reviewed.The purpose of this manuscript is to identify the incidence and progression of rlls in a multicenter study group and to determine their effect on knee functional outcome scores and survivorship at 2 years in patients treated with a single cruciate retaining (cr), uncemented, tka design.227 subjects (227 tkas) were involved in the final follow up.All tkas were implanted with cementless porous coated femoral implant with pegs, a cementless tibial baseplate with 4 porous pegs and a central keel, and a cross-linked, rotating platform articular insert (attune total knee; depuy synthes, warsaw, in).Resurfacing of the patella was left up to the discretion of the surgeon.Adverse events: - rlls in 70 (25%) of the 277 patients in the study group.All patients with rlls at 1 year were followed up for a minimum of 2 years with repeat radiographs.There were no new rlls that emerged at the 2-year follow-up, and none were progressive.-two patients contracted periprosthetic joint infections and were successfully treated with a two-stage exchange.-another patient sustained a quadricep tendon rupture at 3 months after tka.The tendon was repaired, and the patient sustained no further complications.-the final adverse event requiring reoperation involved a 61-year-old female with a preoperative valgus deformity.The tibial implant subsided into varus early in the postoperative period.The obliquity of the implants did not allow for accurate evaluation of rlls, but migration and failure of fixation was obvious.Due to pain, radiographic abnormality, and symptomatic varus deformity, successful revision for aseptic loosening was performed 14 months after the index procedure using a tibial sleeve and stem with retention of the femoral component.No other implants were considered loose or at risk of loosening.Even though implant migration was rare, there was 1 other case of early subsidence of the tibial tray.A 63-year-old female patient, also with a preoperative valgus deformity and osteopenia, was noted to have subtle, early subsidence of the tibial implant migration of the tibial implant into slight varus and extension was estimated to be less than 3 mm, occurred early in the recovery period, and was stable by 3 months.Radiographic images remain unchanged at 3 years of the follow-up, no rlls have been identified, and the patient remains clinically asymptomatic and did not require further surgery.(figure 3).

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 TIBIAL TRAY
• Type of Device: KNEE TIBIAL TRAY
• 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: 15715929
• MDR Text Key: 302921732
• Report Number: 1818910-2022-21929
• 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: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE TIBIAL TRAY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2022
• 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