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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Not Applicable (3189)
Date of Event	08/03/2018
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
Patients knee became infected and a wash out was performed.All cemented components were well fixed and no indication of loosening was observed.Surgeon washed the joint out and swapped the sigma cvd insert out with the original size and thickness insert.Doi: unknown ; dor: (b)(6) 2018; right knee.
Additional Manufacturer Narrative
Product complaint: (b)(4).
Additional Manufacturer Narrative
(b)(4).It is not reasonable to conclude that the device contributed to the patient's infection, 3+ months after implantation.
Additional Manufacturer Narrative
Product complaint: (b)(4).(b)(4) was originally populated with an incorrect g4 date.
Additional Manufacturer Narrative
This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.This does not meet a complaint definition, the electronic complaint record will be voided.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.

• 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: 7823097
• Report Number: 1818910-2018-67936
• Device Sequence Number: 16423161
• 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: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/03/2018

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: 08/03/2018
• Supplement Date Received by Manufacturer: 08/30/2018; 08/30/2018; 08/30/2018; 11/08/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 09/25/2018; 09/25/2018; 09/27/2018; 11/09/2018
• 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: 60 YR
• Patient Weight: 86