MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ2.5 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1961-92-022
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/12/2021
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
Study: (b)(6).Clinical adverse event received for poly spin out.Event is not serious and is considered mild.Event is probably related to device and definitely related to procedure.Date of implant: (b)(6) 2013, date of event: (b)(6) 2020, (right knee).Treatment: closed reduction/manipulation.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since 01-jan-2015.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.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: SIG RP AOX CRV INS SZ2.5 12.5
• 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: 11457238
• Report Number: 1818910-2021-04894
• Device Sequence Number: 3598105
• Product Code: NJL
• UDI-Device Identifier: 10603295076131
• UDI-Public: 10603295076131
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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: 1961-92-022
• Device Catalogue Number: 196192022
• Device Lot Number: 3463102
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 04/08/2021
• 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: MBT CEM KEEL TIB TRAY SZ3; PFC*SIGMA/OV/DOME PAT 3PEG,35; SIGMA CR150 CEM SZ 2.5 RT; STRYKER SIMPLEX P BONE CEMENT FULL DOSE; STRYKER SIMPLEX P BONE CEMENT FULL DOSE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 70