MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIVERSAL STEM 75X14MM FLUTED; JRN : KNEE FEMORAL ACCESSORY

Model Number	86-7414
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Rupture of the component after 8 years from the system.Revision of the left knee prosthesis for rupture of the bolt and adapter resulting in dissociation of the stem/sleeve in the femur.Implant date (b)(6) 2015; surgery: implant of left knee prosthesis.
Additional Manufacturer Narrative
Product complaint # (b)(4).D4-the device catalog number is unknown; therefore, udi is unavailable.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch 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.
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: a manufacturing record evaluation was performed for the finished device product code: 867414, lot: number:605691, and no non-conformances / manufacturing irregularities were identified.
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.
Event or Problem Description
Additional information was received and stated that there was no surgical delay.

• Brand Name: UNIVERSAL STEM 75X14MM FLUTED
• Common Device Name: JRN : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17078553
• Report Number: 1818910-2023-11764
• Device Sequence Number: 14015632
• Product Code: JWH
• UDI-Device Identifier: 10603295217824
• UDI-Public: 10603295217824
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/07/2023

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: 86-7414
• Device Catalogue Number: 867414
• Device Lot Number: 605691
• 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: 05/26/2023
• Supplement Date Received by Manufacturer: 06/06/2023; 06/23/2023; 07/18/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 06/13/2023; 07/05/2023; 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2014
• 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 4.; MBT TRAY SLEEVE POR M/L 45MM.; PFC SIGMA FEM POST AUG SZ4 8MM.; PFC SIGMA FEM POST AUG SZ4 8MM.; PFC*SIGMA DI AUG16MMCO,SZ4LEFT.; PFC*SIGMA TC3 FEM LEFT SZ4.; SIG FEM ADAP +2/-2 OFFSET BOLT.; SIGMA FEM ADAPTER 5 DEGREE.; TC3 RP TIBIAL INSERT S4,12.5.; TC3 RP TIBIAL INSERT S4,12.5.; UNIVERSAL FEM SLV DIS POR 40MM.; UNIVERSAL STEM 75X14MM FLUTED.; UNIVERSAL STEM 75X18MM FLUTED.; UNK KNEE FEMORAL SIGMA.; UNKNOWN KNEE FEMORAL ADAPTOR BOLT.; UNKNOWN KNEE FEMORAL ADAPTOR.; UNKNOWN KNEE FEMORAL SLEEVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Unknown