MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS MED 18MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Catalog Number	198727318
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/13/2025
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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that patient had abrasion at the distal end of the inlay.Patient underwent revision of the left knee and replacement of the inlay component with coupling mechanism.It was further reported that patient had primary implantation with unknown manufacturer implants.On (b)(6) 2020 patient had the revision to s-rom after treatment of infection.
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.H11 additional narrative: added: d9.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 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.H11 additional narrative: corrected: d4 (lot number, primary udi number).If information that was not available for the initial report is obtained, 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 hat 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.H11 additional narrative: added: d10.Corrected: b3, d4 (lot & primary udi number).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: abrasion pe at the distal end of the inlay.Photos were provided for review.(b)(4).The photo investigation revealed wear on the lateral side of the post and upper front section of the condyle.Additionally, it is suspected that due to the heavy wear condition a section of the post has fallen apart of the device.A manufacturing record evaluation was performed for the finished device [198727318 / j64h26], and no non-conformances or manufacturing irregularities were identified.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.The overall complaint was confirmed as the observed condition of the lps univ tib hin ins med 18mm 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: 1) quantity manufactured: (b)(4).2) date of manufacture: 12/09/2019.3) any anomalies or deviations identified in dhr: none.4) expiry date: 11/30/2024.5) ifu reference: 090200773.Device history review: a manufacturing record evaluation was performed for the finished device [198727318 / j64h26], and no non-conformances or manufacturing irregularities were identified.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: abrasion pe at the distal end of the inlay.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device revealed wear on the lateral side of the post and upper front section of one of the condyles.Additionally, it is suspected that due to the heavy wear condition a section of the post has fallen apart of the device.Fragment was not returned for evaluation.A manufacturing record evaluation was performed for the finished device [198727318 / j64h26], and no non-conformances or manufacturing irregularities were identified.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 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 lps univ tib hin ins med 18mm 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: 1) quantity manufactured: (b)(4).2) date of manufacture: 12/09/2019.3) any anomalies or deviations identified in dhr: none.4) expiry date: 11/30/2024.5) ifu reference: 090200773.Device history review: a manufacturing record evaluation was performed for the finished device [198727318 / j64h26], and no non-conformances or manufacturing irregularities were identified.H11 additional narrative: corrected: h3.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: abrasion pe at the distal end of the inlay.Photos were provided for review.The photo investigation revealed wear on the lateral side of the post and upper front section of the condyle.Additionally, it is suspected that due to the heavy wear condition a section of the post has fallen apart of the device.A manufacturing record evaluation was performed for the finished device [198727318 / j64h26], and no non-conformances or manufacturing irregularities were identified.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.The overall complaint was confirmed as the observed condition of the lps univ tib hin ins med 18mm 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:1) quantity manufactured: (b)(4), 2) date of manufacture: 12/09/2019, 3) any anomalies or deviations identified in dhr: none, 4) expiry date: 11/30/2024, 5) ifu reference: 090200773.Device history review: a manufacturing record evaluation was performed for the finished device [198727318 / j64h26], and no non-conformances or manufacturing irregularities were identified.

• Brand Name: LPS UNIV TIB HIN INS MED 18MM
• Common Device Name: LPS AND S-ROM : 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 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22376730
• Report Number: 1818910-2025-11081
• Device Sequence Number: 4413565
• Product Code: KRO
• UDI-Device Identifier: 10603295079606
• UDI-Public: (01)10603295079606(17)241130(10)J64H26
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K091453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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,Followup,Followup

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: 11/30/2024
• Device Catalogue Number: 198727318
• Device Lot Number: J64H26
• 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: 06/13/2025
• Supplement Date Received by Manufacturer: 07/11/2025; 07/14/2025; 08/06/2025; 08/11/2025; 08/22/2025; 09/08/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 07/14/2025; 07/15/2025; 08/08/2025; 08/12/2025; 08/25/2025; 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2019
• 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: SROM*NRH REPL HINGE PIN/MEDIUM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male