MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MBT REVISION CEM TIB TRAY SZ 5; MBT TIBIAL TRAY : KNEE TIBIAL TRAY

Model Number	1294-35-150
Medical Device Problem Codes	Unintended Movement (3026); Migration (4003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Weakness (2145); No Consequences Or Impact To Patient (2199); Ambulation or Postural Difficulties (2544)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
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
Clinical adverse event received for tibial subsidence medium long term : abnormal radiographic evaluation.Event is not serious and is considered mild.Event is possibly related to device and is definitely related to procedure.Date of implantation: (b)(6) 2016.Date of revision #1: (b)(6) 2016.Date of revision #2: (b)(6) 2016.Date of event: (b)(6) 2019.(right knee).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: corrected: h6.Product complaint#: (b)(4).Investigation summary: no device associated with this report was received for examination.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.Device history lot: null.Device history batch: null.Device history review: null.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Added: h6 (patient harm).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : patient product x-ray images have been provided for review alert date: (b)(6) 2020.No device associated with this report was received for examination.Provided images are jpeg files within patient medical records.Depuy synthese considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: MBT REVISION CEM TIB TRAY SZ 5
• Common Device Name: MBT TIBIAL TRAY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9129141
• Report Number: 1818910-2019-106555
• Device Sequence Number: 11381533
• Product Code: NJL
• UDI-Device Identifier: 10603295025986
• UDI-Public: 10603295025986
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1294-35-150
• Device Catalogue Number: 129435150
• Device Lot Number: 720660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 10/23/2019; 01/07/2020; 01/06/2022
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 10/28/2019; 02/04/2020; 01/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COMPETITOR BONE CEMENT; MBT TRAY SLEEVE POR M/L 61MM; PFC SIGMARP STB TB IN 6 10.0; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; SIGMA PS CEM FEM SZ6 R; UNIVERSAL FEM SLV DIS POR 40MM; UNIVERSAL STEM 75X14MM FLUTED; UNIVERSAL STEM 75X16MM FLUTED
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 188 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White