MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIVERSAL STEM 115X16MM FLUTED; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Model Number	86-7430
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/30/2022
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
Patient underwent revision tkr as part of a second stage due to infection.Patient has presented to dr david liu and undergone a poly exchange and washout.At this stage, on opening the knee, the knee was obviously pussy and infected.The knee was washed out and the poly bearing exchanged.Samples taken at this stage are positive for bacteria (sensitive strain).A decision was made to go back into the knee and remove all components as part of a two stage procedure.On opening the knee it appeared relatively angry but not overtly pussy.The components were removed, the tissue debrided and a temporary "kiwi" spacer implanted (attune ps femur and an attune ps rp insert) as part of the temporary spacer.These will be removed in due course and exchanged for a revision system.
Event or Problem Description
Additional information received.The affected side of the patient was the right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Through follow up it is now understood there is no allegation associated against a product malfunction.Review of the x-ray evidence found nothing indicative of a device nonconformance.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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 (mre) was not performed.

• Brand Name: UNIVERSAL STEM 115X16MM 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 RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15973897
• Report Number: 1818910-2022-25257
• Device Sequence Number: 5692995
• Product Code: JWH
• UDI-Device Identifier: 10603295217916
• UDI-Public: 10603295217916
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted 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): 12/13/2022

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: 86-7430
• Device Catalogue Number: 867430
• Device Lot Number: 281224
• 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: 11/30/2022
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2012
• 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 SZ5 4MM; PFC SIGMA FEM POST AUG SZ5 4MM; PFC*SIGMA C/S NPOR FEM RT SZ 5; PFC*SIGMA DIS AUG 4MM,SZ5,RGHT; PFC*SIGMA DIS AUG 4MM,SZ5,RGHT; PFC*SIGMA/OV/DOME PAT 3PEG,41; SIG MOD TIB TRAY CEM COCR 4; SIGMA FEM ADAPTER 5 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; SIGMA STAB GVF INS 4 10MM; UNIVERSAL STEM 115X16MM FLUTED; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male