MAUDE Adverse Event Report: DePuy Orthopaedics Inc US LCS COMPLETE; LCS Complete : Knee Tibial Insert

Catalog Number	129405710
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/22/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had primary left tka surgery done on (b)(6) 2007, where a depuy mbt duofix tray size 4, lcs complete duofix femoral ha coated left lrg+ & lcs complete rp insert sz lg+ 10mm were implanted.These were then revised on (b)(6) 2012 due to pain, and polyethylene 3rd body wear.The femur was left insitu, the tibia was revised to a tibial tray rotating platform m.B.T revision size 4 cemented, with a universal revision stem 75 x14mm and an lcs complete tibial insert rotating platform lcs rp 10mm lg+ gvf.This complaint is related to (b)(4) which captures revision performed on (b)(6) 2026 due to to loosening of the femoral component due to cystic properties on x-ray and bone loss and poly wear of the bearing.
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.Additional narrative: h3, h6: no device associated with this report was received for examination.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LCS COMPLETE
• Common Device Name: LCS Complete : Knee Tibial Insert
• Manufacturer (Section D): DePuy Orthopaedics Inc US; 700 orthopaedic drive; warsaw IN 46581 -098
• Manufacturer (Section G): JTE Warsaw Mfg Site; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50019879
• Report Number: 1818910-2026-12640
• Device Sequence Number: 13406451
• Product Code: NJL
• UDI-Device Identifier: 10603295022220
• UDI-Public: (01)10603295022220(17)120102(10)A78JR4000
• 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: 2007
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 01/02/2012
• Device Catalogue Number: 129405710
• Device Lot Number: A78JR4000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/02/2026
• Initial Report FDA Received Date: 07/27/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown