MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 7-8 LT 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74027281
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Deformity/ Disfigurement (2360); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that, after a left tka surgery had been performed on (b)(6) 2014, due to osteoarthritis, the patient experienced pain and swelling.Bilateral knee aspiration an steroid injection was conducted several times.Bone scans confirmed large joint effusion and patellar maltracking, for which, on (b)(6) 2018, bilateral knee release was performed to address this kneecap positioning problem.In addition, it was later confirmed that the journey ii 9mm polyethylene insert broke off.This component was floating around along with plastic fragments for an undetermined amount of time.This adverse event was solved by performing a revision surgery on (b)(6) 2024, in which the insert was removed and replaced with one size larger.Patient's outcome is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation.However, the photograph was reviewed, and revealed that the device is fractured along the post.The clinical/medical investigation concluded that, a clinical root cause could not be determined.The provided x-rays confirm the report.However, no x-rays images or reports were not provided from 2018 thru 2024, for evaluation or comparison.The undated, unlabeled photo of the insert with the broken post confirms the breakage, consequently, the definitive clinical root cause of the reported adverse event could not be determined.We cannot rule out a possible trauma, the patient¿s age, history of osteoarthritis, neuropathy, gout, bone quality, alcohol usage, activity level as contributory factors.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 12 months revealed a similar event for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed in warnings and precautions that the implant can break or become damaged as a result of strenuous activity or trauma.The patient should be warned that the device does not replace normal healthy bone.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 with inspection drawing, the final inspection includes the verification of part configuration per print.Also, material specification shall control the quality and manufacture ultra-high-molecular-weight polyethylene bar stock.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include surgical technique, patient anatomy, abnormal loading of limb, excessive forces and/or traumatic injury.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.B5 (describe event or problem) and h6 (health effect - clinical code).
Event or Problem Description
It was reported that, after a left tka surgery had been performed on (b)(6) 2014 due to osteoarthritis, the patient experienced pain and swelling.Bilateral knee aspiration an steroid injection was conducted several times.Bone scans confirmed large joint effusion and patellar maltracking, for which, on (b)(6) 2018, bilateral knee release was performed to address this kneecap positioning problem.In addition, it was later confirmed that the jrny ii bcs xlpe art isrt sz 7-8 lt 9mm broke off.This component was floating around along with plastic fragments for an undetermined amount of time.This adverse event was solved by performing a revision surgery on (b)(6) 2024, in which the insert was removed and replaced with one size larger.Patient's outcome is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation.However, the photograph was reviewed and revealed that the device is fractured along the post.The clinical/medical investigation concluded that, the undated, unlabeled photo of the insert with the broken post confirms the breakage, consequently, the definitive clinical root cause of the reported adverse event could not be determined.We cannot rule out a possible trauma, the patient¿s age, history of osteoarthritis, neuropathy, gout, bone quality, alcohol usage, activity level as contributory factors.The patient impact beyond the reported instability, pain, swelling, clicking, revision, and expected transient post-op convalescence period cannot be determined since the patient¿s outcome is unknown.Device batch number was not provided; thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 12 months revealed a similar event for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed in warnings and precautions that the implant can break or become damaged as a result of strenuous activity or trauma.The patient should be warned that the device does not replace normal healthy bone.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 with inspection drawing, the final inspection includes the verification of part configuration per print.Also, material specification shall control the quality and manufacture ultra-high-molecular-weight polyethylene bar stock.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.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 7-8 LT 9MM
• 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: 19052088
• Report Number: 1020279-2024-00682
• Device Sequence Number: 12792361
• Product Code: JWH
• UDI-Device Identifier: 00885556178317
• UDI-Public: 00885556178317
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/06/2024

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 Catalogue Number: 74027281
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 04/05/2024; 05/24/2024; Not provided
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 04/16/2024; 05/27/2024; 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: GNS II RSRF PAT35MM (PN: (B)(4).; JRNY TIB BASE LT SZ 8 (PN:(B)(4).; JRNYII BCS FEM OX LT SZ8 (PN:(B)(4).
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 93 KG