MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT CEM KEEL TIB TRAY SZ5; MBT TIBIAL TRAY : KNEE TIBIAL TRAY

Model Number	1294-33-150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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 or Problem Description
Clinical adverse event received for possible low grade infection.Event is serious and is considered moderate.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2013, date of revision: (b)(6) 2018, date of event: (b)(6) 2023 (left knee).Treatment: aspiration/drainage.
Additional 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 or Problem Description
Clinical notes indicate that on (b)(6) 2023 the patient had a left knee aspiration: medical records report that inflammation markers were slightly elevated with a sedimentation rate of 43 and c-reactive protein is 28.The patient¿s leg is noted to be swollen and the patient reports having pain.There is moderate effusion.The patient reported that they had a trauma where they were hanging from his knee for an hour, so the swelling could be hemarthrosis and secondary synovitis.The patient is on antibiotics and an aspiration was ordered.On (b)(6) 2023, medical records note the patient¿s knee is infected with staph.The surgeon is planning on doing a poly swap with irrigation.The clinical database indicates a revision of the left knee was completed on (b)(6) 2023 as a treatment for infection.The insert was revised.
Additional 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: 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: MBT CEM KEEL TIB TRAY SZ5
• Common Device Name: MBT TIBIAL TRAY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16742569
• Report Number: 1818910-2023-07969
• Device Sequence Number: 5347783
• Product Code: NJL
• UDI-Device Identifier: 10603295025801
• UDI-Public: 10603295025801
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/14/2023

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
• Operator of Device: Health Professional
• Device Model Number: 1294-33-150
• Device Catalogue Number: 129433150
• Device Lot Number: 3592341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 04/07/2023; 04/27/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 04/26/2023; 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PFC*SIGMA/OV/DOME PAT 3PEG,41; SIG RP AOX STB INS SZ5 15; SIGMA PS CEM FEM SZ5 L
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 104 KG