MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIVERSAL STEM 75X18MM FLUTED; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Model Number	86-7418
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Date of Event	12/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.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
Doe: (b)(6) 2020 - (b)(6) 2022: patient continued to have chronic right knee pain, walking difficulty, reduced rom, and swelling after revision.Patient received a right knee ultrasound with aspiration and corticosteroid injection combined with continued physical therapy, which was ineffective.Between (b)(6) 2020 and (b)(6) 2022, the patients pain management physician administered 7 ketamine infusions to treat his right knee chronic regional pain syndrome (crps).The patient also received a right knee genicular nerve radiofrequency ablation (rfa) on (b)(6) 2022.There were no allegations of product defects nor were there any revision surgeries performed.All procedures were administered to treat the patients ongoing chronic pain, swelling, reduced rom, and walking difficulty and will be captured as one event doi: (b)(6) 2019 (tibial tray).(b)(6) 2019 (tibial insert).(b)(6) 2020 (femoral component).Doe: (b)(6) 2020.
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 : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNIVERSAL STEM 75X18MM FLUTED
• Common Device Name: UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14317279
• Report Number: 1818910-2022-08405
• Device Sequence Number: 4794929
• Product Code: JWH
• UDI-Device Identifier: 10603295217848
• UDI-Public: 10603295217848
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2022

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: 86-7418
• Device Catalogue Number: 867418
• 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: 04/26/2022
• Supplement Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 40 MM UNIVERSAL POROUS-COATED FEMORAL SLEEVE; 41 MM 3 PEG OVAL DOME PATELLA; LPS 14MM HINGED TIBIAL INSERT; MBT REVISION ROTATING PLATFORM TIBIAL TRAY SIZE 4; SROM NOILES RIGHT ROTATING HINGE MEDIUM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 125 KG