MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS PC FEM STEM 14.5X150MM BOW; LPS AND S-ROM : KNEE STEMS

Catalog Number	198716213
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Unspecified Infection (1930); Insufficient Information (4580)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Lps revision due to loosening and infection.
Additional Manufacturer Narrative
Product complaint # (b)(4).B3: date of event is an unknown date.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).Investigation summary according to the information received: lps revision loosening.Infection? ¿the product was not returned to depuy synthes, however a photo was provided for review.The photograph attached was reviewed, however lps pc fem stem 14.5x150mm bow cannot be visualized on evidence.Only femoral component and sleeve are shown on evidence.Lps femoral construct, which includes the stem, sleeve and femoral component, appears to not be fully seated into the femur due to more than half of the sleeve, which does not show bone ingrowth, is exposed.With evidence provided, there is not enough evidence to establish if this was the initial position of the construct at the time the devices were implanted.Therefore, loosening allegation cannot be confirmed.An additional event information note (a-10692578) was added to this complaint, confirming implants revised were explanted on 06-sep-2023.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as lps pc fem stem 14.5x150mm bow cannot be visualized on evidence.Based on the investigation findings, a potential cause cannot be established and 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 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 c46168/198716213 number, and no non-conformances /manufacturing irregularities were identified.Device history review a manufacturing record evaluation was performed for the finished device c46168/198716213 number, and no non-conformances /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 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.
Event or Problem Description
Additional information was received and confirmed that there was delay in surgery.
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.

• Brand Name: LPS PC FEM STEM 14.5X150MM BOW
• 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 ; 3035526892
• MDR Report Key: 18369257
• Report Number: 1818910-2023-25801
• Device Sequence Number: 7807012
• Product Code: JWH
• UDI-Device Identifier: 10603295078876
• UDI-Public: 10603295078876
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K033959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 12/20/2023

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: 05/31/2026
• Device Catalogue Number: 198716213
• Device Lot Number: C46168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 01/04/2024; 02/28/2024; 03/12/2024; 04/25/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 01/11/2024; 03/06/2024; 03/12/2024; 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2016
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE REV LPS INSRT XSM 16MM; LPS DISTAL FEM COMP XSM RT; LPS DISTAL FEM COMP XSM RT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male