MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC* MOD PLUS TIBIAL TRAY SZ 3; SIGMA REVISION IMPLANT : KNEE TIBIAL TRAY

Model Number	86-0123
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	05/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This pc is related to (b)(4) which reports the cleaning and re-revision surgery after the confirmation of infection.This pc reports the pain and infection after the revision surgery.It was reported that on an unknown date, the primary surgery was performed.It is also unknown whether the implants used in the primary surgery are jj products or not.On (b)(6) 2022, the revision surgery was performed with the implants in question.The reason for the revision is unknown.After the revision surgery, on (b)(6) 2023, the patient came to the hospital complaining of the sudden knee pain, and the infection was confirmed.No further information is available.Doi; (b)(6) 2022.Dor: (b)(6) 2023.Affected side: unknown.
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.
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.

• Common Device Name: SIGMA REVISION IMPLANT : 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17116880
• Report Number: 1818910-2023-12167
• Device Sequence Number: 7039007
• Product Code: JWH
• UDI-Device Identifier: 10603295215448
• UDI-Public: 10603295215448
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K923807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2023

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: 86-0123
• Device Catalogue Number: 860123
• Device Lot Number: C31752
• 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: 05/31/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2016
• 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 FEM POST AUG SZ3 4MM; PFC*MOD PL TB WDG STP-15MM SZ3; PFC*SIGMA/OV DOME PAT 3 PEG,32; PFCSIG +/-2FEMOFFSET STMBLT; PFCSIG CEM FEM STEM 5DG13X90MM; SIG TIB CEM STM 13X60 2/2.5/3; SIGMA PS CEM FEM SZ3 L; SIGMA STAB GVF INS 3 8MM; SMARTSET GMV GENTAMICIN 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown