MAUDE Adverse Event Report: DEPUY IRELAND¿ 9616671 MBT CEM TIBIAL TRAY SZ3; KNEE TIBIAL TRAY

Catalog Number	129431130
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); Joint Disorder (2373); No Code Available (3191)
Date of Event	10/16/2017
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
Der states that the patient had depuy lcs knee system prior.Patient was coming close to 20 years of implantation.Surgeon decided to remove the implants and put in new revision implants.Update oct 26, 2017 : tibial tray loosening.Loosening occurred from cement to implant interface.Cement manufacturer was unknown.This complaint was updated on oct 26, 2017.
Additional Manufacturer Narrative
The device associated with this reported event was not returned for examination.Depuy considers the investigation closed.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 will be filed as appropriate.
Additional Manufacturer Narrative
Depuy considers the investigation closed at this time.Should the 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 will be filed as appropriate.

• Brand Name: MBT CEM TIBIAL TRAY SZ3
• Common Device Name: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND¿ 9616671; loughbeg, ringaskiddy co.; cork IN ; EI
• MDR Report Key: 7025753
• Report Number: 1818910-2017-28841
• Device Sequence Number: 800081
• Product Code: NJL
• UDI-Device Identifier: 10603295025603
• UDI-Public: 10603295025603
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2017

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: 129431130
• Device Lot Number: 1114230
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2017
• Supplement Date Received by Manufacturer: 11/11/2017; 12/04/2017
• Initial Report FDA Received Date: 11/13/2017
• Supplement Report FDA Received Date: 11/14/2017; 12/05/2017
• 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: 57 YR