MAUDE Adverse Event Report: OSARTIS GMBH SIMPLEX; SIMPLEX HV

Model Number	6194-1-001
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Arthritis (1723); Hypersensitivity/Allergic reaction (1907); Arthralgia (2355); Implant Pain (4561)
Date of Event	11/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's left knee was revised due to inflammation and drainage.It did not appear to be infected, but the patient reported an allergy to methyl methacrylate (this allergy was not reported to the surgeon prior to implantation) in the simplex hv cement used.An i&d was performed and poly insert was revised.

• Brand Name: SIMPLEX
• Common Device Name: SIMPLEX HV
• Manufacturer (Section D): OSARTIS GMBH; auf der beune 101; muenster, hesse 64839 ; GM 64839
• Manufacturer (Section G): OSARTIS GMBH; auf der beune 101; muenster, hesse 64839 ; GM 64839
• Manufacturer Contact: volker stirnal ; auf der beune 101; muenster, hesse 64839 ; GM 64839
• MDR Report Key: 18289492
• Report Number: 9615014-2023-00016
• Device Sequence Number: 12313827
• Product Code: LOD
• UDI-Device Identifier: 04260056885747
• UDI-Public: 04260056885747
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 12/08/2023

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 Model Number: 6194-1-001
• Device Catalogue Number: 6194-1-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TRI CRU RETAIN FEM COMPREF 5510-F-601LOT RDE7H; TRI PRIM BASPLREF 5520-B-600LOT LX940B; TRI X3 PATELLAREF 5550-G-360-ELOT 8NX2; TRI X3 TIB CS INSERTREF 5531-G-610-ELOT AL51D3
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 107 KG