MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. US 1818910 PFCSIGMA FEMCEMSTEM13X90MM7DEG; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Catalog Number	961720
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
(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
(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.

• Brand Name: PFCSIGMA FEMCEMSTEM13X90MM7DEG
• Common Device Name: UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. US 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7895200
• Report Number: 1818910-2018-69947
• Device Sequence Number: 13489850
• Product Code: NJL
• UDI-Device Identifier: 10603295240051
• UDI-Public: 10603295240051
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• 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: 08/29/2006
• Device Catalogue Number: 961720
• Device Lot Number: 216961720
• 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