MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS SEGMENTAL COMPONENT 25MM; LPS AND S-ROM : KNEE ACCESSORY

Catalog Number	198707025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that surgeon revised a total femur for stability reasons related from too much length on the initial segments.He switched for a dm construct to a constrained liner.Doi- (b)(6) 2021 dor- (b)(6) 2024 affected side- right hip.
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
Additional information was received stating that there was no surgical delay reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not perform as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: "although distributed by medtech orthopaedics joint reconstruction, the product is designed, manufactured, and labeled by the manufacturing supplier.The requirement of fda reporting, complaint investigation, root cause, and corrective action is the responsibility of the designing supplier of this item, per the supplier agreement.The product/information will be transferred to the supplier with the complaint problem statement for investigation.The results of the supplier investigation are to be populated into the medtech orthopaedics customer quality complaint management system.Per the supplier agreement, the supplier is responsible for any corrective actions identified during the complaint investigation process." the following investigation was provided by the supplier legal manufacturer: the products were not returned, no product for investigation can be performed.No x ray has been provided, no information.All batches are released in compliance with the supplier specifications.The supplier has no evidence to determine the cause of the complaint.In addition, the supplier implant is not concerned by the event as stated in the 05/29/2024 response.Revision leading to implant replacement can be caused by several factors that cannot be demonstrated due to lack of information.No cause can be identified because the supplier device is not involved by the event.As part of medtech orthopaedics quality process all devices are manufactured, inspected, and released to approved specifications.No further investigation with regard to this complaint is required.The supplier will continue to monitor for trends.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: LPS SEGMENTAL COMPONENT 25MM
• Common Device Name: LPS AND S-ROM : KNEE ACCESSORY
• 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: 19437426
• Report Number: 1818910-2024-12013
• Device Sequence Number: 8321792
• Product Code: JWH
• UDI-Device Identifier: 10603295078517
• UDI-Public: (01)10603295078517(17)310531(10)JG2919
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K033959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2024

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: 198707025
• Device Lot Number: JG2919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 06/06/2024; 10/08/2024
• Initial Report FDA Received Date: 05/31/2024
• Supplement Report FDA Received Date: 06/08/2024; 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2021
• 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: ARTICUL/EZE BALL 22.225+4 NK; BI MENTUM PFRK PE LINER 22 41; LPS PROX FEM TROC BDY 15DEG RT; PINNACLE DM LINER 48_41
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female