MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA CRVD XLK INS 2 8MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	158111108
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Pain (1994); Not Applicable (3189)
Date of Event	05/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Tkr: surgeon, (b)(6), (b)(6) 2018.Primary implant (b)(6) 2017.Patient had a routine tkr and has complained of pain post op with evidence of loosening, instability and the knee is well aligned.Knee was revised and all component were removed.There was no evidence of loosening or instability.There was evidence of chronic inflammation.The knee components were removed and extensive debridement was performed.Infection is queried as a likely cause and a one stage revision to a cemented femur and cemented all poly tibia was performed.Female patient initials (b)(6), aged (b)(6) years, dob: (b)(6) 1945, weight: (b)(6).
Additional Manufacturer Narrative
Product complaint # :(b)(4).Investigation summary :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, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIGMA CRVD XLK INS 2 8MM
• 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: 7587525
• Report Number: 1818910-2018-61790
• Device Sequence Number: 2195494
• Product Code: JWH
• UDI-Device Identifier: 10603295063148
• UDI-Public: 10603295063148
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K040166
• 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,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2018

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: 158111108
• Device Lot Number: 7979582
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 08/03/2018
• 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: 73 YR
• Patient Weight: 60