MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OVAL RESURFACING PAT 32MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71421032
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Muscle Weakness/Atrophy (1967); Loss of Range of Motion (2032); Synovitis (2094); Injury (2348); Inadequate Pain Relief (2388)
Date of Event	01/16/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient suffered a patellar fracture.No delay or injury reported.No procedure specified.
Additional Manufacturer Narrative
The associated complaint device was not returned.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaint can be re-opened.The clinical / medical evaluation concluded that since no relevant clinical medical information was provided a thorough medical assessment could not be performed.No further actions are being taken at this time.We consider this investigation closed.
Additional Manufacturer Narrative
Concomitant medical products contains additional information.
Event or Problem Description
It was reported that, after a left tka had been performed on (b)(6) 2018 with a journey ii xr system, the gii oval resurfacing pat 32mm fractured.On (b)(6) 2019, the clinical investigator had initially assessed this adverse event as non-serious, so the patient was advised to rest.On (b)(6) 2019, the knee was aspired.Later on, a synovectomy was performed on (b)(6) 2019.On (b)(6) 2021, the seriousness of the event was re-assessed as the patient required a revision surgery.The patient claims that the experience with journey ii xr has left him with more pain, less function, and less strength than prior to having any tka.

• Brand Name: GII OVAL RESURFACING PAT 32MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 0447940038246
• MDR Report Key: 8312429
• Report Number: 1020279-2019-00484
• Device Sequence Number: 11251361
• Product Code: HRY
• UDI-Device Identifier: 03596010485069
• UDI-Public: 03596010485069
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/27/2024

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: Health Professional
• Device Model Number: 71421032
• Device Catalogue Number: 71421032
• Device Lot Number: 17JM03761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 01/17/2019; 01/17/2019; 08/27/2021; 09/22/2023; 01/09/2024; 05/24/2024
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 06/05/2019; 06/12/2019; 08/30/2021; 10/13/2023; 01/16/2024; 05/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2017
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 74021166 / 14FM11324G; 74022205 / 17LSL0008C; 74023760 / 17LM06418; 74023860 / 17MM12039
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male