MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 5-6 LT 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74027263
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Loss of Range of Motion (2032)
Date of Event	08/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka was performed on (b)(6) 2016, the patient felt a pop in his knee.This incident happened when the patient started to stand up after being in a deep seated position, after this the patient was unable to flex his knee past 30 deg.This issue was solved by a revision surgery performed on (b)(6) 2022, in which the jrny ii bcs xlpe art isrt sz 5-6 lt 11mm was found broken off.The patient is currently doing well.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation but the pictures were reviewed, and revealed that the insert broke.The clinical/medical investigation concluded that the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.Based on the information provided, the reported adverse event was solved after a revision six-year post implantation in which the jrny ii bcs xlpe art isrt sz 5-6 lt 11mm was found broken off.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.The impact to the patient was the reported fracture, the revision surgery and subsequent post-operative convalescence period.Since the patient is currently doing well, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.A review of the production order 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 implant can break or become damaged as a result of strenuous activity or trauma, and has a finite expected service life and may need to be replaced in the future.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.According to inspection drawing, the final inspection includes the verification of part configuration per print.Also, material specification document establishes the control of quality and manufacture of the materials.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, size selected, surgical technique or postoperative care.The contribution of the device to the reported incident could be corroborated as the device was damaged and it was required a revision surgery to treat this event.Based on this investigation, the need for corrective action is not indicated.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.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 5-6 LT 11MM
• 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: 15535754
• Report Number: 1020279-2022-04293
• Device Sequence Number: 5212200
• Product Code: JWH
• UDI-Device Identifier: 00885556178065
• UDI-Public: 00885556178065
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2026
• Device Model Number: 74027263
• Device Catalogue Number: 74027263
• Device Lot Number: 16CM21433
• 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: 09/09/2022
• Supplement Date Received by Manufacturer: 10/28/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 123 KG