MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI TIB TRAY SZ5 RMLL; EARLY INTERVENTION : KNEE TIBIAL TRAY

Catalog Number	102452500
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Complainant reported he had one partial knee surgery and a second one that was an emergency revision of the first surgery.Complainant stated one of the knee reconstructions failed while he was climbing stairs.Complainant stated the polyurethane came out of place.Complainant stated he has a partial knee replacement conducted to save the knee replacement.When the knee replacement failed a second time, his doctor recommended he obtain a second opinion or obtain another second full knee replacement.Complainant stated he obtained a second opinion and was informed that the second doctor would not perform a knee replacement surgery after another doctor had previously conducted surgery the first time.Second doctor informed the complainant he would perform the full knee replacement surgery with the assistance by first doctor.The complainant stated one of the knee reconstructions failed in 2020.The patient is status-post-right partial knee replacement revision performed on 2019 and a right partial knee replacement performed on 2018.Doi- unknown.Dor- unknown.Affected side- right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).E3: the initial reporter has been removed for confidentiality/privacy.The initial reporter is the patient.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).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 lot#: h54815, product code: 102452500.And no [non conformances /manufacturing irregularities] were identified.

• Brand Name: SIGMA HP UNI TIB TRAY SZ5 RMLL
• Common Device Name: EARLY INTERVENTION : KNEE TIBIAL TRAY
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17390340
• Report Number: 1818910-2023-15118
• Device Sequence Number: 17844661
• Product Code: NPJ
• UDI-Device Identifier: 10603295002413
• UDI-Public: 10603295002413
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2023

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 Catalogue Number: 102452500
• Device Lot Number: H54815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2017
• 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: UNK KNEE TIBIAL INSERT UNI
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male