MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS POROUS STEM 10.5X100MM STR; LPS AND S-ROM : KNEE STEMS

Catalog Number	198726109
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported that complaint is due to broken stem.Implant was revised.
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
A.Please provide the event date.06th of may 2024.B.Is/are the product/s available for return? yes ¿ product is returned and send for inspection.C.Was there a surgical delay? what is the duration of the delay? no, surgery was on (b)(6) 2024.D.Was/were there any adverse consequence/s that affected the patient because of the reported event? no.
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).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.
Event or Problem Description
A) the surgeon performed a fibula osteotomy to access the broken implant.There was no loosening or infection of the implant.B) the break happened when the patient reported hearing a "crack" while standing up from a toilet seat.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : complaint because of broken stem lps porous stem 10.5x100mm str (pictures attached, stem send for analyze).(b)(6) 2024., changed the product with new one.Hcp wants information what is happened with stem? the product was not returned to depuy synthes, however photos were provided for review.The x-ray investigation revealed a fracture on the distal portion of lps porous stem 10.5x100mm str, near the neck of the stem.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.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 lps porous stem 10.5x100mm str would contribute 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 depuy synthes 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 record evaluation was performed for the finished device 618552 number, and no non-conformances nor manufacturing irregularities were identified.
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.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).Investigation summary : complaint because of broken stem lps porous stem 10.5x100mm str (pictures attached, stem send for analyze).(b)(6) 2024., changed the product with new one.Hcp wants information what is happened with stem.The product was not returned to depuy synthes, however photos were provided for review.The x-ray investigation revealed a fracture on the distal portion of lps porous stem 10.5x100mm str, near the neck of the stem.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.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 lps porous stem 10.5x100mm str would contribute 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 depuy synthes 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 record evaluation was performed for the finished device 618552 number, and no non-conformances nor manufacturing irregularities were identified.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: complaint because of broken stem lps porous stem 10.5x100mm str (pictures attached, stem send for analyze).(b)(6) 2024., changed the product with new one.Hcp wants information what has happened with stem? the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found the distal portion of lps porous stem 10.5x100mm str fractured, near the neck of the device.A meeting with the depuy warsaw cpd (commercialized product development) conclude that the damage consists in a high cycle and low stress fatigue over the fractured area.With the information provided is not possible to determine a potential cause at this moment.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 dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.A manufacturing record evaluation was performed for the finished device 618552 number, and no non-conformances nor manufacturing irregularities were identified.The overall complaint was confirmed as the observed condition of the lps porous stem 10.5x100mm str would contribute 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 depuy synthes 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 record evaluation was performed for the finished device 618552 number, and no non-conformances nor manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device 618552 number, and no non-conformances nor manufacturing irregularities were identified.

• Brand Name: LPS POROUS STEM 10.5X100MM STR
• Common Device Name: LPS AND S-ROM : KNEE STEMS
• 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: 19461247
• Report Number: 1818910-2024-12228
• Device Sequence Number: 6734923
• Product Code: JWH
• UDI-Device Identifier: 10603295079231
• UDI-Public: (01)10603295079231(17)241231(10)618552
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: K033959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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,Followup,Followup
• Report Date (Section B): 06/04/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Catalogue Number: 198726109
• Device Lot Number: 618552
• 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: 05/22/2024
• Supplement Date Received by Manufacturer: 06/07/2024; 06/13/2024; 07/12/2024; 07/15/2024; 08/20/2024; 09/25/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 06/13/2024; 06/17/2024; 07/15/2024; 07/16/2024; 08/22/2024; 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2015
• 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: LPS CEMENTED STEM 14X125MM STR.; LPS DISTAL FEM COMP XSM LT.; LPS PROX TIB REPLC COMP XSM.; LPS UNIV TIB HIN INS XSM 12MM.; PFC*SIGMA/OV/DOME PAT 3PEG, 35.; SMARTSET GHV GENTAMICIN 40G.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown