MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REVISION CEM TIB TRAY SZ 2; MBT TIBIAL TRAY : KNEE TIBIAL TRAY

Model Number	1294-35-120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	05/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).(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
It was reported that the patient's knee was infected.All revision components were removed and antibiotic spacer was put in.Doi: (b)(6) 2020, dor: (b)(6) 2020, left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes 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.

• Brand Name: MBT REVISION CEM TIB TRAY SZ 2
• Common Device Name: MBT TIBIAL TRAY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10143556
• Report Number: 1818910-2020-13633
• Device Sequence Number: 19561101
• Product Code: NJL
• UDI-Device Identifier: 10603295025948
• UDI-Public: 10603295025948
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2020

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 Model Number: 1294-35-120
• Device Catalogue Number: 129435120
• Device Lot Number: J60M68
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MBT REVISION CEM TIB TRAY SZ 2; MBT TRAY SLEEVE POR M/L 29MM; PFC*SIGMA DIS AUG 4MM,SZ3,LEFT; PFC*SIGMA DIS AUG 8MM,SZ3,LEFT; SIG RP AOX STB INS SZ3 15; SIGMA FEM ADAPTER 5 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; SIGMA PS CEM FEM SZ3 L; UNIVERSAL STEM 75X16MM FLUTED; UNIVERSAL STEM 75X20MM FLUTED; MBT REVISION CEM TIB TRAY SZ 2; MBT TRAY SLEEVE POR M/L 29 MM; PFC*SIGMA DIS AUG 4 MM, SZ3, LEFT; PFC*SIGMA DIS AUG 8 MM,SZ3,LEFT; SIG RP AOX STB INS SZ3 15; SIGMA FEM ADAPTER 5 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; SIGMA PS CEM FEM SZ3 L; UNIVERSAL STEM 75X16 MM FLUTED; UNIVERSAL STEM 75X20 MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR