MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS SEGMENTAL COMPONENT 65MM; LPS AND S-ROM : KNEE ACCESSORY

Model Number	1987-07-065
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 two surgeries took place prior to this case utilizing jnj implants, 9-30-2020 with the first surgeon at the hospital, and then at another hospital with the another surgeon on (b)(6) 2021.The initial case with the first surgeon was a total femur for treatment of chronic infection.The other surgeon then converted the total femur to a knee fusion as her quad mechanism failed.Ultimately the patient had a hip disarticulation on (b)(6) 2022 as the infection resurfaced.A der was submitted when the second surgeon performed his procedure.No pt harm was created by jnj implants.There was no reported loosening.There was no reported surgical delay.Doi: (b)(6) 2020, dor: (b)(6) 2022, affected side: right knee.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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 65MM
• 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): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15397922
• Report Number: 1818910-2022-17604
• Device Sequence Number: 6198276
• Product Code: JWH
• UDI-Device Identifier: 10603295078562
• UDI-Public: 10603295078562
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K033959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 09/11/2022

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 Model Number: 1987-07-065
• Device Catalogue Number: 198707065
• Device Lot Number: J69H31
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 09/11/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2020
• 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: ARTICUL/EZE BALL 28 +1.5 GR.; ATT REV SLV LPS FEM ADP +5.; LPS PROX FEM STD BODY 15DEG RT.; LPS SEGMENTAL COMPONENT 125MM.; LPS SEGMENTAL COMPONENT 25MM.; LPS SEGMENTAL COMPONENT 65MM.; LPS SEGMENTAL COMPONENT 65MM.; LPS TOTAL FEM SEG COMP 55MM.; PINN CAN BONE SCREW 6.5MMX20MM.; PINN CAN BONE SCREW 6.5MMX25MM.; PINN CAN BONE SCREW 6.5MMX25MM.; PINN LNR CON +4 NEUT 28IDX48OD.; PINN SECTOR W/GRIPTION 48MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 86 KG