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 Muscular Rigidity (1968); Pain (1994)

Event Date 11/21/2022

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 notification received for revision due to pain/stiffness.Date of implant: (b)(6) 2015.Date of revision: (b)(6) 2022 (right knee).Treatment: revision; femoral component, tibial, and insert were revised.Were depuy components removed: yes.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records were received and stated the following: on (b)(6) 2015, patient received a cemented right attune posterior stabilized fixed bearing total knee replacement to address bilateral severe tri-compartmental osteoarthritis.Patella was resurfaced.Cement manufacturer was not identified.There were no complications.On (b)(6) 2022, patient was seen in the clinical setting, presenting with pain and stiffness of her right knee.She had her other knee revised in the past to address aseptic loosening (knee manufacturer and other details were not provided).Radiographs of her knee show radiolucency around the tibial tray at the cement to implant interface, consistent with tibial implant loosening.Knee will require revision--diagnostically treated in the interim period with a right knee joint aspiration to determine if there is evidence of infection.

• 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: 16272185
• MDR Text Key: 308473784
• Report Number: 1818910-2023-02495
• 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: 01/31/2023

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 TIBIAL INSERT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 01/31/2023
• Supplement Dates Manufacturer Received: 02/28/2023; 03/15/2023
• Supplement Dates FDA Received: 03/13/2023; 03/15/2023
• 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: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN KNEE FEMORAL; UNKNOWN KNEE PATELLA; UNKNOWN KNEE TIBIAL TRAY
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic