MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA CRVD XLK INS 2.5 8MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	158112108
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	01/24/2018
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
Revision tkr dr (b)(6), (b)(6) hospital (b)(6) 2018.Patient underwent primary tkr on (b)(6) 2013 (dr (b)(6), (b)(6) hospital).Patient has presented with a progressively painful knee and reduced range of motion.X rays appear to show some abnormal activity below the tibial tray.Bone scans shown"hot" areas below the tibial tray.Tibial loosening was suspected.On opening the knee (dr (b)(6), (b)(6) hospital) the tibial tray appeared to be fairly well fixed.The bone cement was well fixed to the underlying bone.The tibial tray was removed along with the cement.An mbt revision tray with sleeve and stem implanted.A new 10mm cr insert was implanted.Knee appeared stable on the table.(b)(6).
Additional Manufacturer Narrative
Product complaint: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will 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 2.5 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: 7280478
• Report Number: 1818910-2018-53651
• Device Sequence Number: 1066517
• Product Code: JWH
• UDI-Device Identifier: 10603295063261
• UDI-Public: 10603295063261
• 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: 2013
• 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): 01/24/2018

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: 158112108
• Device Lot Number: 6172004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 02/19/2018
• Supplement Report FDA Received Date: 09/27/2018
• 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: 65 YR