MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM COCR NP RT SZ 7; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74021257
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Fibrosis (3167)
Date of Event	06/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a cori-assisted tka surgery performed on (b)(6) 2021, the patient presented arthrofibrosis in the right knee.A revision surgery was set to be performed on the (b)(6) 2021 to treat this adverse event.The patient current health status is unknown.
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, per the operative note the mua was performed due to arthrofibrosis.The range of motion increased intraoperatively to ¿satisfactory¿.Arthrofibrosis is a well-known potential post-operative occurrence and does not support a component malperformance.Patient¿s health impact is unknown beyond the stated information provided.A review of the provided documents did not provide any insight into the reported issue of right knee arthrofibrosis requiring a manipulation procedure.Therefore, no further clinical assessment of the reported issue can be rendered.Should additional information be provided, the clinical/medical investigation task may be reopened.A complaint history review found related failures for the listed batch; this failure mode will be monitored for future complaints for any necessary corrective actions.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 the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but are not limited to patient reaction and/or condition.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, 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.
Additional Manufacturer Narrative
Additional information: b5, d10, h6.
Event or Problem Description
It was reported that, after a cori-assisted tka surgery performed on (b)(6) 2021, the patient developed arthrofibrosis in the right knee (symptom onset: (b)(6) 2021).The patient underwent manipulation under anesthesia on (b)(6) 2021 to treat this adverse event.On the (b)(6) 2021 the patient was appointed as recovered.

• Brand Name: JRNY II CR FEM COCR NP RT SZ 7
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12171164
• Report Number: 1020279-2021-05986
• Device Sequence Number: 937031
• Product Code: JWH
• UDI-Device Identifier: 00885556615195
• UDI-Public: 00885556615195
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/29/2021

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: 74021257
• Device Catalogue Number: 74021257
• Device Lot Number: B1803650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 10/08/2021; 12/06/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 10/11/2021; 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: JOURNEY TIBIA BASE NP RT SZ 7 / 21CM0452; JRNY BCS PAT RESRF RD 35 MM STD / 20HM18697; JRNY II CR ISRT XLPE RT SZ 7-8 9MM / 14CM18173
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 112 KG