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

Catalog Number UNK KNEE TIBIAL INSERT

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

Patient Problems Hematoma (1884); Ambulation Difficulties (2544); Joint Laxity (4526)

Event Date 08/31/2022

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

Clinical adverse event received for pseudolaxity with valgus stress, varus alignment, and instability event is serious and is considered severe.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2022, date of revision: (b)(6) 2022, date of event: (b)(6) 2022, (left knee).Treatment: revision; femoral, tibial, and insert were removed.Depuy products used: catalog id: 3312040 lot id: 3684084, component type: cement, description: smart set cmw 1 40g.

Event Description

Primary operative notes (b)(6) 2022 indicated that the patient received a left total knee replacement due to osteoarthritis.Competitor implants were utilized along with depuy cement.The surgery was completed without indication of complication by the surgeon.Office notes (b)(6) 2022 indicated that the patient was experiencing bowing of her left knee and difficulty ambulating.She had significant varus alignment.She had pseudolaxity with valgus stress.Xray revealed loose femoral component with subsidence secondary to poor bone quality.Revision operative notes (b)(6) 2022 indicated that the patient received a left total knee revision due to left periprosthetic femur fracture.The patient had insufficiency/periprosthetic fracture of the medial femoral condyle allowing the femoral component to go into varus.This created significant malalignment of the lamina and significant laxity.She was very osteoporotic.Upon entering the joint, a slight hematoma was encountered and evacuated.The femoral component was noted to have subsided into varus and was also loose.All implants were revised, and a competitor hinge knee was implanted.The surgery was completed without indication of complication by the surgeon.

Manufacturer Narrative

Product complaint # : (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5, h6 (clinical codes).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary device associated with this report was not received for examination.All available x-rays and photographs were reviewed and no defect was found.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 the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation mre was not performed.

• Brand Name: UNKNOWN KNEE TIBIAL INSERT
• 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: 15442715
• MDR Text Key: 300119673
• Report Number: 1818910-2022-17995
• 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: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE TIBIAL INSERT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2022
• 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
• Treatment: DEPUY CMW 1 40G; UNK KNEE FEMORAL; UNK KNEE TIBIAL TRAY
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Hispanic
• Patient Race: White