MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HP UNI INS SZ3 7MM RMLL AOX; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	102456307
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
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.H11 additional manufacturer narrative: 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 during an unspecified surgical procedure it was observed that the insert device could not be inserted.It was reported that the procedure was successfully completed, without surgical delay.There were no reports of injuries, medical intervention or prolonged hospitalization.No additional information could be provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees hat the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary according to the information received, ¿it was reported that on (b)(6) 2025, the patient underwent an unknown surgery with the product in question.In the surgery, the product could not be inserted.¿ the product returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis revealed that the implant edges exhibit signs of deformation and slight surface scratches, which are consistent with attempted implantation attempts.No other defects that could have contributed to the reported event were observed.The sigma® high performance partial knee unicondylar surgical technique (dsus/jrc/1114/0582) provides detailed guidance for the proper steps required to achieve correct final implantation.Adhering to these steps ensures that the insert locks securely into the tibial base as intended, thereby reducing the risk of improper seating and preventing potential damage to the uni insert.The observed damaged condition suggests an improper alignment when trying to introduce the uni insert through the tibial base locking edge.This would contribute to the difficulty/inability to mate the insert with the tibial component following multiple insertion attempts.A functional test was not performed since mating device was not returned for evaluation.However, due to the visual damage observed, the difficulty/inability to assemble mating devices can be confirmed.The overall complaint was confirmed as the observed condition of the hp uni ins sz3 7mm rmll aox would contribute to the complained device issue.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 search of the depuy synthes nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Corrected: h3.

• Brand Name: HP UNI INS SZ3 7MM RMLL AOX
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 23789926
• Report Number: 1818910-2025-21744
• Device Sequence Number: 5520512
• Product Code: HRY
• UDI-Device Identifier: 10603295501855
• UDI-Public: (01)10603295501855(17)280531(10)M3853T
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 102456307
• Device Lot Number: M3853T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/27/2025
• Supplement Date Received by Manufacturer: 01/06/2026; 02/23/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/07/2026; 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2023
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown