MAUDE Adverse Event Report: OSSUR HF RHEO KNEE XC; PROSTHETIC KNEE

Model Number	RKNXC0003
Medical Device Problem Codes	Human-Device Interface Problem (2949); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Damage to Ligament(s) (1952); Muscle/Tendon Damage (4532)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient tripped over paving stones and hurt his shoulder.Patient indicates that it is not clear whether the tripping was due to knee malfunction or if he just tripped himself.An mri scan indicated that rotator cup of patient's right shoulder is torn (upper tendon to lift arm).
Event or Problem Description
Patient tripped over paving stones and hurt his shoulder.Patient indicates that it is not clear whether the tripping was due to knee malfunction or if he just tripped himself.An mri scan indicated that rotator cup of patient's right shoulder is torn (upper tendon to lift arm).The shoulder was operated and patient will fully recover.

• Brand Name: RHEO KNEE XC
• Common Device Name: PROSTHETIC KNEE
• Manufacturer (Section D): OSSUR HF; grjothals 1-5; reykjavik, 110 ; IC 110
• Manufacturer Contact: katla axelsdottir ; grjothals 1-5; reykjavik, 110 ; IC 110
• MDR Report Key: 19972545
• Report Number: 3003764610-2024-00007
• Device Sequence Number: 8543462
• Product Code: ISW
• UDI-Device Identifier: 05690977467804
• UDI-Public: 05690977467804
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

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: Lay User/Patient
• Device Model Number: RKNXC0003
• Device Catalogue Number: RKNXC0003
• Device Lot Number: HF367058
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown