MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMP RP INSERT MED 15MM; LCS COMPLETE : KNEE TIBIAL INSERT

Catalog Number	129405315
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a hair in the sterile implant box.There was no patient involvement or surgical delay.
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.
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.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: customer complaint about a hair in the sterile implant box.The product was returned to j&j medtech orthopaedics for evaluation.The complaint unit was forwarded to the manufacturing site j&j medtech orthopaedics raynham.Visual inspection of the returned device found a hair under the shrink wrap on the outside of the carton package of the lcs comp rp insert med 15mm.It is worth mentioning that the hair was not found inside the sterile inner pouch or outer blister.The observed condition of the device has been addressed through the j&j medtech orthopedic quality management system.Based on the manufacturing investigation, it has been determined that the complaint is considered an isolated incident.The defect found in this complaint is a cosmetic defect that does not impact the safety, fit, and functionality of the device.Man is the assignable cause for this nonconformance specifically application error.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the lcs comp rp insert med 15mm would have contributed to the complained device issue.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through j&j medtech orthopaedics quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot:1) quantity manufactured: 12.2) date of manufacture: 2/25/2025.3) any anomalies or deviations identified in dhr: none.4) expiry date: 1/31/2030.5) ifu reference: (b)(4).Device history review: a manufacturing record evaluation was performed for the finished device product code: 129405315 lot number: m84u60, and no non-conformances or manufacturing irregularities were identified.H11 additional narrative: corrected: h3.

• Brand Name: LCS COMP RP INSERT MED 15MM
• 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 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 21872491
• Report Number: 1818910-2025-05817
• Device Sequence Number: 20763168
• Product Code: NJL
• UDI-Device Identifier: 10603295021964
• UDI-Public: (01)10603295021964(17)300131(10)M84U60
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 129405315
• Device Lot Number: M84U60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 04/22/2025; 06/09/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 04/23/2025; 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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
• Patient Sex: Unknown