MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS FEM TO SLEEVE ADAPTER +0; LPS AND S-ROM : KNEE FEMORAL ACCESSORY

Model Number	1987-06-000
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 the patient originally had sigma revision components that were revised on (b)(6) 2019 because the femoral component was internally rotated which led to poor patella tracking and subluxation.On (b)(6) 2019, an lps hinged knee and metaphyseal sleeve were implanted to address the patella tracking issue.Since this procedure, the femoral construct had subsided approximately 3cm.These components needed to be revised to restore the joint line.The femoral construct was removed and a competitor cone was implanted along with a 200mm cemented lps stem, xsmall lps segmental femur and 25mm segment.Doi: (b)(6) 2019, dor: (b)(6) 2020, right knee.
Additional Manufacturer Narrative
Product complaint (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
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.

• Brand Name: LPS FEM TO SLEEVE ADAPTER +0
• Common Device Name: LPS AND S-ROM : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9829984
• Report Number: 1818910-2020-07797
• Device Sequence Number: 19014551
• Product Code: KRO
• UDI-Device Identifier: 10603295078487
• UDI-Public: 10603295078487
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K091453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2020

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 Model Number: 1987-06-000
• Device Catalogue Number: 198706000
• Device Lot Number: J3998F
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 03/19/2020; 04/14/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 03/31/2020; 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LPS DISTAL FEM COMP XSM RT; LPS FEM TO SLEEVE ADAPTER +0; LPS SEGMENTAL COMPONENT 25MM; LPS UNIV TIB HIN INS XSM 12MM; MBT REV TIB TRAY SIZE 4 15MM; MBT TRAY SLEEVE POR M/L 37MM; PFC*SIGMA/OV/DOME PAT 3PEG,41; UNIVERSAL FEM SLV FUL POR 34MM; UNIVERSAL STEM 115X16MM FLUTED; UNIVERSAL STEM 75X16MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention