MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HP UNI INS SZ4 7MM LMRL AOX; KNEE IMPLANT - TIBIAL INSERT

Catalog Number	102455407
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported that although the surgeon inserted the poly in the same normal manner they always do, the poly would not seat in the tibia tray no matter what.The poly had no visual blemishes, however the anterior portion of the poly would not seat down in the tibial tray.There was nothing left in this patient due to several attempts to impact the poly and the surgery was not delayed in any manner.Affected side-unknown knee.
Additional Manufacturer Narrative
Product complaint: (b)(4).Investigation summary: no device associated with this report was received for examination.A manufacturing record evaluation was performed for the finished device below and no non-conformances or manufacturing irregularities were identified.Product code: 102455407.Product name: hp uni ins sz4 7mm lmrl aox.Lot number: m8524f.A manufacturing record evaluation was performed for the finished device product description: hp uni ins sz4 7mm lmrl aox, product code: 102455407, lot number: m8524f, and no non-conformances / manufacturing irregularities were identified.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 sz4 7mm lmrl aox.Product code: 102455407.Lot number: m8524f.Date of manufacturing: 17 - feb - 2025.Expiry date: 31 - jan - 2030.Quantity to be manufactured: (b)(4).

• Brand Name: HP UNI INS SZ4 7MM LMRL AOX
• Common Device Name: KNEE IMPLANT - TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24322569
• Report Number: 1818910-2026-02903
• Device Sequence Number: 9931131
• Product Code: HRY
• UDI-Device Identifier: 10603295501602
• UDI-Public: (01)10603295501602(17)300131(10)M8524F
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 102455407
• Device Lot Number: M8524F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2025
• 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
• Patient Age: 58 YR
• Patient Sex: Male