MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIVERSAL STEM 75X14MM FLUTED; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Catalog Number	867414
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Inadequate Osseointegration (2646)
Date of Event	10/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision of lcs complete revision components.Implants revised due to suspected infection and loosening.Very minimal bone growth on the stem and sleeve.Implants were removed very easily.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? no, did the patient require revision surgery or hardware removal? yes, facility name of original implant was device explanted? true, hardware/explant removal due to: infection and loosening, did patient require revision surgery? true, if yes, date of revision surgery.Reason for revision surgery.Infection and loosening, patient status/ outcome / consequences yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? pain due to infection and loosening, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study unknown, ip-(b)(4) device property of none, device in possession of none, ip-(b)(4) device property of none, device in possession of none, ip-(b)(4) device property of none, device in possession of none, ip-(b)(4) device property of none, device in possession of none, ip-(b)(4) device property of none, device in possession of none, ip- (b)(4) device property of none, device in possession of none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received: a.Was the infection confirmed? was it the main reason for the revision? -this was not officially confirmed to me.I have not had any word.The implants were also loosening so were revised due to this.
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.Added: b5, d10 concomitant.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: revision of lcs complete revision components.Implants revised due to suspected infection and loosening.Very minimal bone growth on the stem and sleeve.Implants were removed very easily.The product was not returned to j&j medtech orthopaedics; however, photos were provided for review.The photo investigation revealed that the device exhibits extraction damage.However, with the information and as no chronological x-rays were provided the reported allegation of loosening cannot be confirm.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the observed condition of the universal stem 75x14mm fluted would have not contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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 records evaluation (mre) was not performed.

• Brand Name: UNIVERSAL STEM 75X14MM 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): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20567685
• Report Number: 1818910-2024-22666
• Device Sequence Number: 7391901
• Product Code: JWH
• UDI-Device Identifier: 10603295217824
• UDI-Public: (01)10603295217824(17)260228(10)753342
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 10/30/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: 867414
• Device Lot Number: 753342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 10/30/2024; 01/20/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 11/13/2024; 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2016
• 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: LCS COMP VVC INS STD+ 10MM.; LCS COMPLETE REVFEM CEM L STD+.; MBT REVISION CEM TIB TRAY SZ 4.; MBT TRAY SLEEVE POR M/L 53MM.; UNIVERSAL FEM SLV DIS POR 34MM.; UNIVERSAL STEM 75X14MM FLUTED.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown