MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFC*SIGMA C/S NPOR FEM LT SZ 3; SIGMA KNEE PRIMARY : KNEE FEMORAL

Catalog Number	960043
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/23/2018
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.Concomitant med products: mbt cem keel tib tray sz2.5 knee tibial tray component; pfc*sigma c/s npor fem lt sz 3 knee femur component; pfc sigmarp stb tb in 3 10.0 knee tibial insert component; unknown knee patella component; smartset gmv gentamicin 40g bone cement x 2.(b)(4).
Event or Problem Description
Subject: (b)(6).Clinical adverse event received for migration/loosening of the tibial component.Event is not serious and is considered moderate.Event is definitely related to device and not related to procedure.Doi: (b)(6) 2007.Doe: (b)(6) 2018.(left knee).
Additional Manufacturer Narrative
Product complaint # (b)(4).Review of additional information from medical records identified that the previously reported (b)(4) loss of or failure to bond" was made in error.The revision operative records indicated that the device was in fact, well-fixed and not loose.Therefore, there is no reportable product failure, and the previous reports are null and void.Please disregard the medwatch reports for this product.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8003964
• Report Number: 1818910-2018-73475
• Device Sequence Number: 289179
• Product Code: JWH
• UDI-Device Identifier: 10603295232230
• UDI-Public: 10603295232230
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K950010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/08/2018

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: 960043
• Device Lot Number: 097043AB
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 11/08/2018; 09/25/2018; 12/18/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 11/09/2018; 11/28/2018; 12/20/2018
• 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: 70 YR
• Patient Weight: 91