MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS; LPS AND S-ROM : KNEE ACCESSORY

Catalog Number	198707030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930)
Date of Event	04/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had wound breakdown post multiple revision tka leading to potential contamination of their prostheses.The surgeon chose to removal all well fixed and well functioning components and place a static spacer fashioned with lps components without delay nor patient harm.A gastroc flap was performed by the plastic surgeon post spacer placement in hopes of healing this wound.This patient has had multiple surgeries since this date to address complications with implants being exchanged.The dates were and the der numbers are listed (b)(6) 2026 (b)(6), (b)(6) 2026 ,(b)(6) ,(b)(6)2026 (b)(6).Doi: (b)(6) 2026 dor: (b)(6) 2026 affected side: right knee.
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 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 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 perform.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: there is 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.Added: d10 concomitant.

• Brand Name: LPS
• Common Device Name: LPS AND S-ROM : KNEE ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 25192766
• Report Number: 1818910-2026-08880
• Device Sequence Number: 10157342
• Product Code: JWH
• UDI-Device Identifier: 10603295078524
• UDI-Public: (01)10603295078524(10)MF5955
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K033959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

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 Catalogue Number: 198707030
• Device Lot Number: MF5955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ATT REV SLV LPS FEM ADP +10; ATTUNE REV LPS INSRT XXSM 12MM; ATUN FEM SLV M/L 30MM FULL POR; ATUN PRESSFIT STR STEM14X110MM; ATUN TIB SLV M/L 37MM FULL POR; ATUNE REV RP TIB BASE SZ 3 CEM; CONTROL CABLE W/CABLE SLEEVE; LPS DISTAL FEM COMP XXSM RT; LPS SEGMENTAL COMPONENT 25MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 100 KG