MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE RP TIB BASE SZ 4 CEM; KNEE TIBIAL TRAY

Catalog Number	150610004
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Pain (1994); No Consequences Or Impact To Patient (2199); Limited Mobility Of The Implanted Joint (2671)
Date of Event	01/01/2018
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.
Event or Problem Description
There is no cement attached to the undersurface of the tibial tray.;even-though it was well fixed.Femur inspire being loose had cement mantle attached to it.Cement used in this case was palacos g.Patient was operated on (b)(6) 2017.Was doing fine but had a periprosthetic fracture which had to be revised.So, main concern was periprosthetic fracture, debonding was observed while taking out implants.This tibial debonding can be investigated for reasons as it should have had good bone cement interface.Doi: (b)(6) 2017; dor: unknown; unknown affected side.
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.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Photographs and x-ray images were provided for review.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may 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: ATTUNE RP TIB BASE SZ 4 CEM
• Common Device Name: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 7233775
• Report Number: 1818910-2018-52529
• Device Sequence Number: 1826937
• Product Code: NJL
• UDI-Device Identifier: 10603295042563
• UDI-Public: 10603295042563
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2018

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: 150610004
• Device Lot Number: 8537102
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2018
• Supplement Date Received by Manufacturer: 02/09/2018; 11/28/2018
• Initial Report FDA Received Date: 02/01/2018
• Supplement Report FDA Received Date: 02/12/2018; 11/28/2018
• 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