MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX STB INS SZ2.5 10; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	196192121
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	04/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
Patient had a right total knee done on (b)(6)2016.Patient fell recently.Exhibited knee pain.X-rays showed possible loose tibia.Cemented tibia was loose.There was no cement adhering to the tibial plate.Cement was stuck on the tibial plateau and in the canal.Was the loosening of the implant caused by the fall or original cement used.We were unable to determine what type of cement was used.The hospital logs do not go back that far to verify it.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: patient had a right total knee done on (b)(6) 2016.Pt fell recently, exhibited knee pain.X-rays showed, possible loose tibia.Cemented tibia was loose.There was no cement adhering to the tibial plate.Cement was stuck on the tibial plateau and in the canal was the loosening of the implant caused by the fall or original cement used.We were unable to determine, what type of cement was used.The hospital logs do not go back that far to verify it.The product was not returned to depuy synthes.However, photos were provided for review.The x-ray investigation revealed, nothing indicative of a device nonconformance.As the device was not returned, an as-received condition could not be assessed.And a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed.As the observed, condition of the sig rp aox stb ins sz2.5 10, would not contribute to the reported adverse event.Based on the investigation findings, it has been determined, that no corrective and/or preventative action is proposed.There is no indication, that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed, for the finished device 8156929 number.And no non-conformances nor manufacturing irregularities were identified.Corrected: d4: (primary udi number).

• Brand Name: SIG RP AOX STB INS SZ2.5 10
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19305747
• Report Number: 1818910-2024-10508
• Device Sequence Number: 7310187
• Product Code: NJL
• UDI-Device Identifier: 10603295076445
• UDI-Public: (01)10603295076445(17)200630(10)8156929
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• 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): 05/13/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 196192121
• Device Lot Number: 8156929
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2015
• 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: HP STRL QUICK DRL PINS; HP STRL THREADED PINS HEADED; MBT CEM KEEL TIB TRAY SZ2.5; PFC*SIGMA/RD/DOME PAT 3PEG,32; SIGMA PS CEM FEM SZ2.5 R; UNK CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female