MAUDE Adverse Event Report: DePuy Orthopaedics Inc US UNIVERSAL STEM; Universal Knee Stems and Sleeves : Knee Stems

Catalog Number	867414
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Pain (1994)
Type of Reportable Event	Serious Injury

• Brand Name: UNIVERSAL STEM
• Common Device Name: Universal Knee Stems and Sleeves : Knee Stems
• Manufacturer (Section D): DePuy Orthopaedics Inc US; 700 orthopaedic drive; warsaw IN 46581 -098
• Manufacturer (Section G): JTE Warsaw Mfg Site; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50173040
• Report Number: 1818910-2026-13526
• Device Sequence Number: 10034923
• Product Code: JWH
• UDI-Device Identifier: 10603295217824
• UDI-Public: (01)10603295217824
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K241000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 867414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown