MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY FEM OX NP BCS RT SZ 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	74021113
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Pain (1994); Loss of Range of Motion (2032); Arthralgia (2355); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	02/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, after a tka prosthesis construct had been implanted on the patient¿s right knee on (b)(6) 2022, the patient experienced a mechanical complication of the joint, osteophyte formation, pain at the joint, restricted mobility and plica syndrome.An additional surgery was performed on (b)(6) 2022 to treat this adverse event.During this procedure, an open arthrotomy of the patella with modelling and denervation was performed, along with the resection of the osteophytes, plicar resection and resection of node rings with plastic reconstruction in congenital anomalies.A 32mm resurfaced patella was implanted.The patient reports to be experiencing some swelling and pain after this intervention.
Event or Problem Description
It was reported that, after a tka prosthesis construct had been implanted on the patient¿s right knee on (b)(6) 2017, the patient experienced a mechanical complication of the joint, osteophyte formation, pain at the joint, restricted mobility and plica syndrome.An additional surgery was performed on 18-feb-2022 to treat this adverse event.During this procedure, an open arthrotomy of the patella with modelling and denervation was performed, along with the resection of the osteophytes, plicar resection and resection of node rings with plastic reconstruction in congenital anomalies.A 32mm resurfaced patella was implanted.The patient reports to be experiencing some swelling and pain after this intervention.
Additional Manufacturer Narrative
Corrected data: b5, d10 (insert identity updated), h6 (health effect - clinical code).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the reported osteophyte formation is not related to the implanted devices.The reported pain and restricted mobility in the right knee may be consistent with the noted findings of osteophytes and/or plica syndrome.However, based on the limited information provided, the clinical root cause of the pain cannot be confirmed.The patient impact beyond that which has been reported cannot be determined.However it has been reported that the patient has still experienced pain and swelling following the procedure.No further clinical 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 systems revealed that the patient should be warned of surgical risks, and made aware of possible adverse effects and states that outcome data reported in some registries suggest that resurfacing the patella during primary tka should be considered since it may decrease the rate of revision, provided the patient¿s anatomical and clinical conditions allow, this information has been identified in warnings and precautions and in description of system section.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.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.
Additional Manufacturer Narrative
Additional information updated: d10 (concomitant entry added for the patellar implant).Corrected data: b5.
Event or Problem Description
It was reported that, after a tka prosthesis construct had been implanted on the patient¿s right knee on (b)(6) 2017, the patient experienced a mechanical complication of the joint, osteophyte formation, pain at the joint, restricted mobility and plica syndrome.An additional surgery was performed on (b)(6) 2022 to treat this adverse event.During this procedure, an open arthrotomy of the patella with modelling and denervation was performed, along with the resection of the osteophytes, plicar resection and resection of node rings with plastic reconstruction in congenital anomalies.The patient reports to be experiencing some swelling and pain after this intervention.
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that, after a tka prosthesis construct had been implanted on the patient¿s right knee on (b)(6) 2007, the patient experienced a mechanical complication of the joint, osteophyte formation, pain at the joint, restricted mobility and plica syndrome.An additional surgery was performed on (b)(6) 2022 to treat this adverse event.During this procedure, an open arthrotomy of the patella with modelling and denervation was performed, along with the resection of the osteophytes, plicar resection and resection of node rings with plastic reconstruction in congenital anomalies.The patient reports to be experiencing some swelling and pain after this intervention.

• Brand Name: JOURNEY FEM OX NP BCS RT SZ 3
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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: 14579299
• Report Number: 1020279-2022-02728
• Device Sequence Number: 5165115
• Product Code: JWH
• UDI-Device Identifier: 03596010554055
• UDI-Public: 03596010554055
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/23/2022

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: Health Professional
• Device Expiration Date: 11/28/2015
• Device Model Number: 74021113
• Device Catalogue Number: 74021113
• Device Lot Number: 05LM06880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2022
• Supplement Date Received by Manufacturer: 07/11/2022; 07/14/2022; 07/29/2022; 07/29/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 07/13/2022; 07/18/2022; 08/22/2022; 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2005
• 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: 74022213; 74023231; PN: 74022213 / LOT: UNKNOWN; PN: 74023234 / LOT: 09AM20910; PN: 74024832 / LOT: 15EM14663
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 64 KG