MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*CVD TB INS SZ5, 12.5MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	98-4159
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Osteolysis (2377); No Code Available (3191)
Date of Event	01/27/2020
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
Clinical notification received for revision of left total knee to address osteolysis and polyethylene wear.Date of implantation: (b)(6) 1995.Date of revision #1: (b)(6) 2010 (insert).Date of revision #2: (b)(6) 2020.(left knee).Treatment: femur, tibial tray, tibial insert were revised to revision components.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Per internal procedures, the event information and any investigational inputs received as part of required follow up were reviewed.For this investigation, no immediate action was required as no alleged deficiency with the device was identified.Monitor: exempt per wi-7915, known possible complication of joint replacement surgery.No device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional previous reports against the provided product code/lot code combination.Based on the inability to find any additional previous reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.The reported event is considered one of the possible complications of joint replacement.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.Without the physical complaint sample associated with this report, it was not possible to determine if the device failed to meet specification at the time it was released for distribution.The device associated with this event was used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No product contribution to the reported event was identified.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.

• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9842434
• Report Number: 1818910-2020-08239
• Device Sequence Number: 19023846
• Product Code: JWH
• UDI-Device Identifier: 10603295252498
• UDI-Public: 10603295252498
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 98-4159
• Device Catalogue Number: 984159
• Device Lot Number: 048159V
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/14/2020
• 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: PFC*CVD TB INS SZ5, 12.5MM; UNKNOWN KNEE FEMORAL; UNKNOWN KNEE TIBIAL TRAY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 88