MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT TRAY SLEEVE POR M/L 37MM; MBT TIBIAL TRAY : KNEE TIBIAL TRAY ACCESSORY

Model Number	1294-54-100
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was revised to address aseptic loosening of the tibial tray at the unknown interface.Depuy cement was used.It was also reported that the tibial stem migrated.Doi: (b)(6) 2015, dor: (b)(6) 2021, unknown knee.
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
Additional information received indicated that the affected side involved in this event was the left side and the stem in the tibia migrated is what the surgeon said.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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 TRAY SLEEVE POR M/L 37MM
• Common Device Name: MBT TIBIAL TRAY : KNEE TIBIAL TRAY ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12788826
• Report Number: 1818910-2021-24856
• Device Sequence Number: 5094935
• Product Code: NJL
• UDI-Device Identifier: 10603295026419
• UDI-Public: 10603295026419
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1294-54-100
• Device Catalogue Number: 129454100
• Device Lot Number: 666639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 11/16/2021; 11/25/2021
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 11/23/2021; 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2015
• 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: MBT REVISION CEM TIB TRAY SZ 3; MBT TRAY SLEEVE POR M/L 37MM; SMARTSET GMV 40G US EO; TC3 RP TIBIAL INSERT S3,10.0; UNIVERSAL STEM 75X14MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 76 KG