MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR INS XLPE LAT 1-2 RT 8MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIN, CEMENT, POLY/MET/POLY

Model Number 74021152

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Dislocation (2374); Inadequate Osseointegration (2646)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.(b)(4).

Event Description

It was reported that, after a right tka surgery was performed on the (b)(6) 2020, the patient experienced lateral dislocation of right knee joint.This adverse event was treated by a revision surgery on (b)(6) 2021, for which it is unknown which devices were explanted and/or replaced.Per the collected evidence related to the subject's clinical course, she has recovered from this procedure.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Corrected data: d1, d4 (catalog number, lot number, expiration date and udi number), d10, g4 (510k), h4, h6 (health effect - clinical code).

Manufacturer Narrative

Section h3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per case details, approximately one year post total knee arthroplasty surgery, a clinical study patient underwent a revision due to a lateral dislocation of the right knee joint.Reportedly, the patient has recovered.As of the date of this medical investigation, the requested clinical documentation including which devices were explanted or replaced has not been provided; therefore, there were no clinical factors found which would have definitively contributed to the event.The patient impact beyond the reported is not anticipated as it has been communicated, the patient¿s current health status is ¿recovered/resolved,¿ with ¿no remedial therapy¿ received.Therefore, no further clinical/medical assessment can be rendered.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed devices.A review of the instructions for use documents for knee systems revealed in possible adverse effects that dislocation and subluxation can result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.A review of the risk management files 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 these products and event.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.Factors that could contribute to the reported event include traumatic injury, patient anatomy, and/or or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should the devices 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.B5: describe event or problem and h6: medical device problem code.

Event Description

It was reported that, after a right tka surgery was performed on (b)(6) 2020, the patient experienced lateral dislocation of the right knee joint.This adverse event was treated by a revision surgery on (b)(6) 2021.Per the collected evidence related to the subject's clinical course, she has recovered from this procedure.

• Brand Name: JRNY II XR INS XLPE LAT 1-2 RT 8MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIN, CEMENT, POLY/MET/POLY
• 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: 16187841
• MDR Text Key: 307522186
• Report Number: 1020279-2023-00119
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556615508
• UDI-Public: 00885556615508
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K152726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2023

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
• Device Operator: Health Professional
• Device Model Number: 74021152
• Device Catalogue Number: 74023810
• Device Lot Number: 17LM16144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/17/2023
• Supplement Dates Manufacturer Received: 01/12/2023; 02/08/2023
• Supplement Dates FDA Received: 01/20/2023; 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 71932636/GEN II 7.5MM RESUR PAT 32MM; 74022292/JRNY II XR BASEPLATE SZ 2 RT; 74023712/JRNY II XR INS XLPE MED 1-2 RT 10MM; 74023810/JRNY II XR INS XLPE LAT 1-2 RT 8MM; PN: 71932636 / LOT: 19LM06570; PN: 74021152 / LOT: 18MM00176; PN: 74022292 / LOT: 19DSL0005B; PN: 74023712 / LOT: 16KM16680
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Sex: Female