MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 HP UNI INS SZ3 8MM LMRL AOX; KNEE IMPLANT - TIBIAL INSERT

Catalog Number	102455308
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the information is unknown, not available or does not apply, the section/field of the form is left blank.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 on (b)(6) 2025, the patient underwent an uka.During surgery, the bearing could not be inserted.Despite careful check of cement use, the insert in question could not be inserted.Although the surgeon re-hammered it several times, there was concern about the fixation.Therefore, the size was changed to 7mm.The size change made it 1mm loose, the surgeon determined that there was no problem.The surgical time was extended approximately 5 minutes due to this event.The surgery was completed successfully.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.Product description: hp uni ins sz3 8mm lmrl aox product code: 102455308 lot number: m36k42 manufacturing date: 19-may-2023 expiry date: 30-apr-2028 quantity manufactured: (b)(4).As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot product description: hp uni ins sz3 8mm lmrl aox product code: 102455308 lot number: m36k42 manufacturing date: 19-may-2023 expiry date: 30-apr-2028 quantity manufactured: (b)(4).Device history review a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities were identified.

• Brand Name: HP UNI INS SZ3 8MM LMRL AOX
• Common Device Name: KNEE IMPLANT - TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21313100
• Report Number: 1818910-2025-02180
• Device Sequence Number: 12822966
• Product Code: HRY
• UDI-Device Identifier: 10603295501565
• UDI-Public: (01)10603295501565(17)280430(10)M36K42
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 02/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 102455308
• Device Lot Number: M36K42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown