MAUDE Adverse Event Report: DePuy Orthopaedics Inc US UNIVERSAL STEM INSERT HANDLE; Hip Instruments : Handles

Catalog Number	259807460
Medical Device Problem Codes	Device-Device Incompatibility (2919); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction

• Brand Name: UNIVERSAL STEM INSERT HANDLE
• Common Device Name: Hip Instruments : Handles
• Manufacturer (Section D): DePuy Orthopaedics Inc US; 700 orthopaedic drive; warsaw IN 46581 -098
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50858523
• Report Number: 1818910-2026-16396
• Device Sequence Number: 9651641
• Product Code: LXH
• UDI-Device Identifier: 10603295148449
• UDI-Public: (01)10603295148449(10)PG330442
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 259807460
• Device Lot Number: PG330442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/01/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/22/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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