MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP RT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74021155
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Contracture (4528)
Date of Event	12/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery had been performed, the clinical subject suffered from a flexion contracture (rom 90/0/0).The adverse event was treated with manipulation under anesthesia.Patient is still recovering.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that this clinical study case reports that the patient underwent a manipulation under anesthesia 3 months post tka due to flexion contracture.Pre-mua x-rays were reviewed by the medical director, and it doesn't appear to contribute to the arthrofibrosis, although there is radiolucency under the posterior tibial base plate and medial side as well.; everything else looks okay.The requested surgical reports have not been provided.Therefore, the patient impact beyond the mua cannot be determined.Without clinically relevant supporting documentation a thorough medical investigation cannot be rendered.Should clinically relevant documentation/ information become available, the clinical/medical task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Some potential probable causes could be alignment, fit/size of device used or wear.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
Event or Problem Description
It was reported that, after a tka surgery had been performed on (b)(6) 2020, the clinical subject suffered from a flexion contracture (rom 90/0/0) (onset date: (b)(6) 2020).This adverse event was treated with manipulation under anesthesia (mua) on (b)(6) 2020.Patient was recovered on (b)(6) 2021.

• Brand Name: JRNY II CR FEM OX NP RT SZ 5
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11300068
• Report Number: 1020279-2021-01054
• Device Sequence Number: 12020816
• Product Code: JWH
• UDI-Device Identifier: 00885556422847
• UDI-Public: 00885556422847
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 74021155
• Device Catalogue Number: 74021155
• Device Lot Number: 20AM25461
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CN: 71421029, LN: 20CM24984; CN: 74022214, LN: 19BM05981A; CN: 74025631, LN: 20AM02342; CN: 71421029, LN: 20CM24984; CN: 74022214, LN: 19BM05981A; CN: 74025631, LN: 20AM02342
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR