MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIG RP AOX CRV INS SZ4 15; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1961-92-043
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Renal Failure (2041); No Code Available (3191)
Date of Event	01/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
Der states that the patient has infection in joint.I and d with a poly swap was performed.(b)(6) 2017 ; (b)(6) 2018 ; right knee.
Additional Manufacturer Narrative
(b)(4).No device associated with this report was received for examination.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.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).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.  patient code: no code available ((b)(4)) used to capture the device revision and replacement.
Event or Problem Description
On (b)(6) 2018, the patient underwent a right knee revision with tibial insert exchange with an irrigation and debridement to address infection.It was noted the patient also experienced significant kidney injury around the time of the revision.Specific detail were not provided.The injury had resolved by the time of the second revision.
Additional Manufacturer Narrative
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 been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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 if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIG RP AOX CRV INS SZ4 15
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7215029
• Report Number: 1818910-2018-51902
• Device Sequence Number: 13486743
• Product Code: NJL
• UDI-Device Identifier: 10603295076223
• UDI-Public: 10603295076223
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/02/2018

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: 1961-92-043
• Device Catalogue Number: 196192043
• Device Lot Number: 8043000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 11/06/2018; 04/07/2020; 05/14/2020
• Initial Report FDA Received Date: 01/24/2018
• Supplement Report FDA Received Date: 11/07/2018; 04/17/2020; 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR