MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP RT SZ 5; PROSTH,KNEE,PATFEMTIB,SEMCONSTR,CEMNT,POL/METL/POL

Model Number	74021155
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis (2100); Injury (2348)
Date of Event	07/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that in the left leg a deep vein thrombosis was developed by the patient after procedure.Medication therapy was performed as action taken against the adverse event.The patient is recovering.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms per complaint details, approximately 2 weeks post right tka, a patient developed a left dvt (ae#1/sade) which required medication therapy.It was communicated that ¿¿although there were no obvious symptoms, a lower extremity vein echo performed on 12th day after surgery revealed a partially floating thrombus from the right fibular vein and posterior tibial vein to the popliteal vein, so internal medicine of xarelto was started on the same day.¿ per the crf/discharge the patient was given dvt prophylaxis and the crf/ae, the patient/event was ¿recovering/resolving¿ with ongoing medication therapy.Dvts are a known potential post-operative complication.Based on the information provided in the crfs, the root cause of the event could not be definitively concluded and the patient impact beyond the reported event and subsequent medication therapy could not be determined.No further medical assessment is warranted at this time.A complaint history review found related failures; 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 risk management files and instructions for use found that the reported failure was documented appropriately.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
Additional Manufacturer Narrative
H10: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, approximately 2 weeks post right tka, a patient developed a left dvt which required medication therapy.Newly attached xr study #169/8008 diagnostic report appears to support a ¿side¿ discrepancy on the previously provided ae form as the provided translated diagnostic deep vein observation form reports a ¿right popv-pev, ptv, and soleus vein thrombus with the central end of the thrombus¿ partially floating and not fixed to the vessel wall¿ with ¿positive blood flow signals around the thrombus.¿ it was previously communicated that ¿although there were no obvious symptoms, a lower extremity vein echo performed on 12th day after surgery revealed a partially floating thrombus from the right fibular vein and posterior tibial vein to the popliteal vein, so internal medicine of xarelto was started on the same day.¿ per the crf/discharge form, the patient was given dvt prophylaxis and per the crf/ae form, the patient/event was ¿recovering/resolving¿ with ongoing medication therapy.Dvts are a known potential post-operative complication and this does not support a component malperformance.Based on the information provided in the crfs, the root cause of the event could not be definitively concluded and the patient impact beyond the reported event and subsequent medication therapy could not be determined.No further medical assessment is warranted at this time.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 for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for knee system revealed that thrombosis has been identified as a possible adverse effect.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury and/or patient condition.The contribution of the device to the reported event could not be corroborated.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.Internal complaint reference number: case-2020-00021346-1.

• Brand Name: JRNY II CR FEM OX NP RT SZ 5
• Common Device Name: PROSTH,KNEE,PATFEMTIB,SEMCONSTR,CEMNT,POL/METL/POL
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 10601128
• Report Number: 1020279-2020-04931
• Device Sequence Number: 3273128
• Product Code: JWH
• UDI-Device Identifier: 00885556422847
• UDI-Public: 00885556422847
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2022

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: 74021155
• Device Catalogue Number: 74021155
• Device Lot Number: 20CM05491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 06/24/2021; 05/05/2022
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 06/28/2021; 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2018
• 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: GEN II RESURF PATELLA PN:71932636/LOT:19HM20100; JRNY II BASEPLATE PN:74022293/LOT:18CSL0013B; JRNY II INSERT LAT PN:74023830/LOT:19CM09203; JRNY II INSERT MED PN:74023731/LOT:17GM14204; GEN II RESURF PATELLA PN:71932636/LOT:19HM20100; JRNY II BASEPLATE PN:74022293/LOT:18CSL0013B; JRNY II INSERT LAT PN:74023830/LOT:19CM09203; JRNY II INSERT MED PN:74023731/LOT:17GM14204
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 79 YR
• Patient Sex: Female