MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REV TIB TRAY SIZE 3 15MM; MBT TIBIAL TRAY : KNEE TIBIAL TRAY

Model Number	1294-35-315
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); No Code Available (3191)
Date of Event	07/29/2020
Type of Reportable Event	Serious Injury
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
Revision of unknown parts of s-rom nrh-knee because of fracture of femoral stem right side.Doi: unknown, dor: (b)(6) 2020.A surgical delay was not reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device was unable to confirmed the reported event.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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.Updated: d11, from unknown stem to srom nrhfem w/pin sm rt 66x62.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).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.

• Brand Name: MBT REV TIB TRAY SIZE 3 15MM
• 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: 10478870
• Report Number: 1818910-2020-19207
• Device Sequence Number: 11414279
• Product Code: NJL
• UDI-Device Identifier: 10603295026020
• UDI-Public: 10603295026020
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/29/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1294-35-315
• Device Catalogue Number: 129435315
• Device Lot Number: D28FHA000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 08/14/2020; 09/10/2020; 10/06/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 09/08/2020; 09/15/2020; 10/06/2020
• 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: LPS UNIV TIB HIN INS SM 12MM; MBT TRAY SLEEVE POR M/L 61MM; SROM NRHFEM W/PIN SM RT 66X62; SROM*NRH REPL HINGE PIN/XSM/SM; UNIVERSAL FEM SLV DIS POR 46MM; UNIVERSAL STEM 150X20MM FLUTED; UNIVERSAL STEM 75X20MM FLUTED; UNKNOWN KNEE FEMORAL STEM; LPS UNIV TIB HIN INS SM 12 MM; MBT TRAY SLEEVE POR M/L 61 MM; SROM*NRH REPL HINGE PIN/XSM/SM; UNIVERSAL FEM SLV DIS POR 46 MM; UNIVERSAL STEM 150X20 MM FLUTED; UNIVERSAL STEM 75X20 MM FLUTED; UNKNOWN KNEE FEMORAL STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR