MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. US 1818910 PFC* MOD PLUS TIBIAL TRAY SZ 4; SIGMA REVISION IMPLANT : KNEE TIBIAL TRAY

Catalog Number	860124
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Pain (1994); Not Applicable (3189)
Date of Event	10/12/2009
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
The patient was revised to address pain and tibial tray and femoral component loosening at the cement to implant interface.Depuy cement was used in the previous operation.Doi: (b)(6) 2005 (stem).Doi: (b)(6) 2007 (femoral).Dor: (b)(6) 2009.
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.Device history lot:product code (b)(4), lot number (b)(4).Device history review : dhr reviewed no deviations were noted.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 REVISION IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7895189
• Report Number: 1818910-2018-69945
• Device Sequence Number: 1909445
• Product Code: JWH
• UDI-Device Identifier: 10603295215455
• UDI-Public: 10603295215455
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K884796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2018

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 Expiration Date: 05/22/2010
• Device Catalogue Number: 860124
• Device Lot Number: 1650124C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 12/21/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention