MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS DISTAL FEM COMP XSM LT; LPS AND S-ROM : KNEE FEMORAL

Model Number	1987-13-105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Swelling/ Edema (4577)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had implants removed and replaced due to suspected infection.Implants were placed on 2 dates per the records on (b)(6) 2019 (first 5 items listed) and on (b)(6) 2022.Patient experienced repeated effusions.Surgeon has sent multiple aspirations but no cultures were not positive.Cell counts and lab values were elevated, but not reaching a level to diagnose infection.During the procedure, 2 separate tissue samples were sent to pathology, and 3 and 4 wbc/hpf were found, again elevated but not definitive.Surgeon chose to removal all components and replace in a one stage fashion after a thorough debridement and irrigation.Antibiotic beads were placed in canals and surrounding soft tissues and vancomycin was added to gent cement.There was no surgical delay.Doi: (b)(6) 2019, dor: (b)(6) 2022, affected side: left 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.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.
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 DISTAL FEM COMP XSM LT
• Common Device Name: LPS AND S-ROM : KNEE FEMORAL
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15470347
• Report Number: 1818910-2022-18512
• Device Sequence Number: 17211888
• Product Code: JWH
• UDI-Device Identifier: 10603295078685
• UDI-Public: 10603295078685
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 09/22/2022

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 Expiration Date: 01/31/2024
• Device Model Number: 1987-13-105
• Device Catalogue Number: 198713105
• Device Lot Number: J23T34
• 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: 09/01/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2019
• 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: ATTUNE REV LPS INSRT XSM 16MM; ATUN PRESSFIT STR STEM14X160MM; ATUN PRESSFIT STR STEM14X160MM; ATUN TIB SLV M/L 45MM FULL POR; ATUNE REV RP TIB BASE SZ 6 CEM; CONTROL CABLE W/CABLE SLEEVE; LPS DISTAL FEM COMP XSM LT; LPS FEM TO SLEEVE ADAPTER +0; LPS SEGMENTAL COMPONENT 25MM; LPS UNIV TIB HIN INS XSM 12MM; PFC*SIGMA/OV/DOME PAT 3PEG,41; UNIVERSAL FEM SLV FUL POR 46MM; UNIVERSAL STEM 75X20MM FLUTED; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 115 KG