MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIG RP AOX CRV INS SZ3 17.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	196192034
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348); Impaired Healing (2378); Post Operative Wound Infection (2446)
Date of Event	08/01/2018
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
Subj: (b)(4).Associated study: rotating platform dots.Clinical adverse event received for delayed wound healing (superficial subcutaneous dysvascular changes with eschar and delayed healing) and subsequent revision related to infection and wound breakdown.Event is serious and is considered mild in severity.Event is not related to device and is possibly related to procedure.Doi: (b)(6) 2018; doe: (b)(6) 2018; dor: (b)(6) 2018; (right knee).Patient placed on keflex 500mg qid and underwent revision surgery with insert exchange.Event is considered resolved as of (b)(6) 2018.
Additional Manufacturer Narrative
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.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: SIG RP AOX CRV INS SZ3 17.5
• 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: 7864806
• Report Number: 1818910-2018-68983
• Device Sequence Number: 16641366
• Product Code: NJL
• UDI-Device Identifier: 10603295076193
• UDI-Public: 10603295076193
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2018

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: 196192034
• Device Lot Number: 8201096
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 10/19/2018; 11/08/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 10/24/2018; 11/08/2018
• 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 Weight: 109