MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP LT SZ 4; PRSTHS,KNEE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMRMTLPLYMR

Catalog Number	74022224
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/14/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to loosened component.
Additional Manufacturer Narrative
The affected complaint devices were not returned for evaluation.Our clinical investigation noted that the revision reports confirm the proximal tibia implant was loose.However, without the x-rays or the requested clinical information the root cause of the loosening cannot be determined.The reported questionable fall cannot be ruled out as a contributing factor.A ct scan report from the 6 month follow up reports the components are intact and well seated.This adverse event has been reported as resolved with residual effects.No further clinical/medical assessment is warranted at this time.Our investigation included a review of the manufacturing records for the listed batches which did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the parts revealed no prior complaints for the listed batch number.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: JOURNEY TIBIA BASE NP LT SZ 4
• Common Device Name: PRSTHS,KNEE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMRMTLPLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7302901
• Report Number: 1020279-2018-00252
• Device Sequence Number: 16475871
• Product Code: JWH
• UDI-Device Identifier: 03596010554321
• UDI-Public: 03596010554321
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2018

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: 05/26/2025
• Device Catalogue Number: 74022224
• Device Lot Number: 15EM19769
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 07/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4); (B)(4)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 53 YR