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

Catalog Number UNK KNEE TIBIAL STEM

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

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Literature article entitled "a useful tip for removal of a well-fixed trabecular metal tibial cone" written by michael j.Blackmer, brett g.Brazier, and joseph e.Alhadeff.Published by techniques in orthopaedics published online/accepted by publisher 4 dec 2020 was reviewed.The article's purpose was to follow the case of a (b)(6) male who required a repeat 2-stage revision of an infected total knee implant that included a porous tantalum tibial cone (competitor).It is indicated the patient previously underwent a 2-stage revision involving unknown manufacturer products.After the first 2-stage revision the patient underwent a revision arthroplasty with a posterior stabilized, rotating platform implant with diaphyseal-engaging stem (pfc sigma rotating platform total condylar 3) and a trabecular metal tibial cone (competitor product).In the early postoperative period following implantation of depuy products, the patient complained of purulent drainage, pain, effusion, as well as an elevated c-reactive protein.The patient underwent a tibial insert exchange followed by a 6-week course of iv antibiotics through a picc line followed by a 3-month course of oral antibiotics.It is unclear if infection was cleared.Upon completion of the antibiotic course, he developed recurrent effusions, pain, and an elevation in inflammatory markers.At this time, the decision was made to attempt a second 2-stage exchange arthroplasty with revision of depuy products.There is no mention of a patella component or indication of cement manufacturer.Radiographic and intra-operative images can be found on pages 1, 2, and 3 of the literature article.Depuy products with known adverse event(s): 1) pfc tibial insert x 2 2) pfc tibial tray 3) pfc tibial stem 4) pfc tibial sleeve 5) pfc femoral component 6) pfc femoral stem 7) pfc femoral sleeve adverse events: 1) first revision with tibial insert exchange to address pain, effusion, drainage, and infection.2) second revision with revision of all products to address pain, effusion, and infection.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Reviewing the x-rays and medical photos on the article, no evidence have been found of an implant fracture, disassociation oy anything indicative of a device non-conformance.There is no evidence to confirm defective device to cause those symptoms in the patient.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot : a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

• Brand Name: UNKNOWN KNEE TIBIAL STEM
• Type of Device: TIBIAL STEM
• 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12688465
• MDR Text Key: 283967850
• Report Number: 1818910-2021-23389
• Device Sequence Number: 1
• Product Code: HRY
• 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: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE TIBIAL STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2021
• 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