MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFC SIGMARP STB TB IN 6 25.0; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	962167
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Not Applicable (3189)
Date of Event	08/05/2018
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.Concomitant med products: pfc sigmarp stb tb in 6 25.0; sigma fem adapter 5 degree; sig fem adap +2/-2 offset bolt; sig tib cem stm 13x60 2/2.5/3; sigtibcemstm 13x30 1.5/2/2.5/3; unknown knee femoral; unknown knee tibial tray; unknown bone cement.
Event or Problem Description
The patient was revised to address infection and loosening of the femoral component at bone to cement interface.Cement manufacturer is unknown.It was also reported that the tibia was well fixed but taken out due to infection.Doi: 2015 for the femoral adaptor, femoral bolt and (2) tibial stem , doi: (b)(6) 2018 for femur, insert and tibial tray, dor: (b)(6) 2018 , left knee.
Additional Manufacturer Narrative
Product complaint # :(b)(4).Investigation summary : no device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate. .

• Brand Name: PFC SIGMARP STB TB IN 6 25.0
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0998
• MDR Report Key: 7832238
• Report Number: 1818910-2018-68112
• Device Sequence Number: 11045204
• Product Code: NJL
• UDI-Device Identifier: 10603295241560
• UDI-Public: 10603295241560
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2018

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 Catalogue Number: 962167
• Device Lot Number: 3582876
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 09/18/2018
• 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: 72 YR