MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4-RT 18MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74027237
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/27/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017 the subject is noted with a revision of the total knee arthroplasty as a consequence of having a fall.Medical records do not state damage to study knee; however, it is noted that subject on left side ¿smashed the knee cap and the femur in 3 places¿.It is noted that damages to the right side (study side) are minor and that subject underwent minor revision surgery.Date of resolution is (b)(6) 2017 and poly exchange was performed for what is noted to be instability and breakage of the implant.
Additional Manufacturer Narrative
The affected journey ii bcs articular insert was not returned for evaluation.Therefore a product analysis could not be performed.However, device details were provided.Therefore, our investigation including the manufacturing records and complaint history review was conducted.The review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.Our clinical evaluation noted that the x-ray provided were undated and do not indicate a reason for the tibial component and insert revision.Based on the limited information provided and without the return of the device for evaluation the root cause of the reported instability and breakage of the device cannot be definitively concluded.However, the patient fall cannot be ruled out as a contributing factor.The future impact to the patient beyond the revision cannot be determined.No further clinical/medical assessment is warranted at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 3-4-RT 18MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8409883
• Report Number: 1020279-2019-01034
• Device Sequence Number: 13917998
• Product Code: JWH
• UDI-Device Identifier: 00885556179314
• UDI-Public: 00885556179314
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 74027237
• Device Lot Number: 13BM17076
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 101