MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT CEM KEEL TIB TRAY SZ6; MBT TIBIAL TRAY : KNEE TIBIAL TRAY

Catalog Number	129433160
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	07/02/2018
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
The patient was revised to address loosening of the tibial component and patella component at the cement to implant interface.Cement manufacturer is unknown.Doi: (b)(6) 2012; dor: (b)(6) 2018; left knee.
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MBT CEM KEEL TIB TRAY SZ6
• Common Device Name: MBT TIBIAL TRAY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7721865
• Report Number: 1818910-2018-65239
• Device Sequence Number: 658536
• Product Code: NJL
• UDI-Device Identifier: 10603295025818
• UDI-Public: 10603295025818
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2018

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: 129433160
• Device Lot Number: 3487401
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 08/21/2018
• 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: 71 YR