MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMP RP INSERT STD 12.5MM; LCS COMPLETE : KNEE TIBIAL INSERT

Catalog Number	129405412
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
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
Revised 20 years old lcs tkr for anterior knee pain / patella wear.Surgeon removed old poly insert and replaced.Resurfaced patella with medialised dome attune patella (off-label), this was surgeon preference and did not want to use lcs patella option.
Event or Problem Description
Additional information received: a.Was there any surgical delay? no delay.B.What is the affected side involved in this event? left.
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 that 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.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: revised lcs tkr for anterior knee pain / patella wear.20 years old.Surgeon removed old poly insert and replaced.Resurfaced patella with medialised dome attune patella (off-label), this was surgeon preference and did not want to use lcs patella option.The product was not returned to j&j medtech orthopaedics, however photos were provided for review.The photo investigation revealed that the lcs comp rp insert std 12.5mm has signs of slightly wear at the condyles and deformation at the edges.Additionally it can be seen that the central post was fractured, most likely caused by the explantation process.In support of the evaluation performed, the observed damage of the lcs comp rp insert std 12.5mm may have been caused by exposure to irregularities in the weight loading of the device and moments generated.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A manufacturing records evaluation (mre) was not performed since a finished good lot number was not provided for this device.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 confirmed as the observed condition of the lcs comp rp insert std 12.5mm would have 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.Device history lot: a manufacturing records evaluation (mre) was not performed since a finished good lot number was not provided for this device.

• Brand Name: LCS COMP RP INSERT STD 12.5MM
• Common Device Name: LCS COMPLETE : KNEE TIBIAL INSERT
• 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
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19134257
• Report Number: 1818910-2024-08594
• Device Sequence Number: 4631198
• Product Code: NJL
• UDI-Device Identifier: 10603295022022
• UDI-Public: 10603295022022
• 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 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): 04/18/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 129405412
• Device Lot Number: BF0224095/1
• 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: 04/09/2024
• Supplement Date Received by Manufacturer: 05/13/2024; 02/05/2025
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 05/15/2024; 02/05/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown