MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG MOD TIB TRAY CEM COCR 4; KNEE TIBIAL TRAY

Model Number	1581-40-000
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/22/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the patient presented with loosening of tibial component at bone to cement interface and significant collapse of tibial prosthesis.Patient had same issue on the opposite knee.Surgeon believes patient has insufficient bone stock to support std prosthesis.Tibial and femoral revision takes place successfully and no patient harm occurs.Doi- (b)(6) 2019.Dor- (b)(6) 2023.
Event or Problem Description
Additional information received: a.What was the allegation against the femoral and insert? b.Please provide the product details of unknown bone cement c.How was the cement prepared for use? d.What equipment was used to prepare/mix the cement? e.What was the timing to mix and the time between mixing and setting? f.What equipment was used to deliver the cement? g.Was the product available for return? answers: a.No allegation was made against any component.The insert is attached to the tray and has to be removed to remove the tray.The femur, while well fixed, could not be used with revision components which was the surgeon's intention, so it was removed b all known details were noted in previous submission.C.Surgeon routinely has cemented mixed by hand in a basin with a tongue depressor.D.See "c" e.Unknown, until mixed??? f.Tongue depressor directly to components, and hand packed into bone after pulsed lavage and drying g.No.
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.H10 additional narrative: added: b5, d4 (lot, udi), g4 and h4 d1, d2, d4 (catalog) and g1.

• Brand Name: SIG MOD TIB TRAY CEM COCR 4
• Common Device Name: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork IN ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17287857
• Report Number: 1818910-2023-13791
• Device Sequence Number: 6319424
• Product Code: JWH
• UDI-Device Identifier: 10603295064909
• UDI-Public: 10603295064909
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K032151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 07/10/2023

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: 1581-40-000
• Device Catalogue Number: 158140000
• Device Lot Number: 8784489
• 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: 06/22/2023
• Supplement Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2018
• 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: SIGMA PS CEM FEM SZ5 L; SIGMA STAB XLK INS 4 15MM; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 79 KG