MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HP UNI INS SZ3 7MM LMRL AOX; KNEE IMPLANT TIBIAL INSERT

Catalog Number	102455307
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on an unknown date; the patient underwent an uka surgery with the implant in question.In the surgery, the bearing could not be inserted during implantation.The surgeon carefully checked for cement placement, but the bearing could not be inserted.The implant was re-inserted several times, but there were doubts about its stability, so the size was changed to 8mm.After changing the size, it became about 1mm tighter, but the surgeon determined that this was not a problem.The surgery was completed successfully with about 5 minutes surgical delay.No further information is available.
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.
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 that 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.H10 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.It was reported that on an unknown date, the patient underwent an uka surgery with the implant in question.In the surgery, the bearing could not be inserted during implantation.The surgeon carefully checked for cement placement, but the bearing could not be inserted.The implant was re-inserted several times, but there were doubts about its stability, so the size was changed to 8mm.After changing the size, it became about 1mm tighter, but the surgeon determined that this was not a problem.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device found that the hp uni ins sz3 7mm lmrl aox presents signs of deformation and slightly scratches which are consistent with implantation attempts.The sigma® high performance partial knee unicondylar surgical technique (dsus/jrc/1114/0582 rev.4), provide guidance to for a correct final implantation steps to be followed.Following these steps will successfully locking the insert into the base as intended, preventing the uni insert to be damaged.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.A dimensional inspection was unable to be performed due to the post-manufacturing damage.A search of the j&j medtech orthopaedics nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.The overall complaint was confirmed as the observed condition of the hp uni ins sz3 7mm lmrl aox would have contributed to the complained 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 j&j medtech orthopaedics 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 j&j medtech orthopaedics nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.H11 additional narrative: corrected: h3.

• Brand Name: HP UNI INS SZ3 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: 22727978
• Report Number: 1818910-2025-13767
• Device Sequence Number: 8989705
• Product Code: HRY
• UDI-Device Identifier: 10603295501558
• UDI-Public: (01)10603295501558(17)280430(10)M3792U
• 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,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: 102455307
• Device Lot Number: M3792U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 08/25/2025; 10/17/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 08/26/2025; 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown