MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 LT11; PRSTHSS, KNEE, PTLLFMRTBL, SM-CNSTRND, CMNTD, PLYMR/MTL/PLYMR

Model Number	74024832
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed on (b)(6), due to dislocation.The revision was performed and only the poly was swapped with a new implant.The patient is currently under recovery, the surgeon didn't advise medication.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.A clinical analysis indicated that the provided implantation report and charts sticks were reviewed and are non-contributory.Without the requested revision operative report, radiographs or return of the device a thorough medical investigation cannot be rendered.This event is unresolved; therefore, the patient impact is unknown.Should any additional medical information be provided, this complaint will be re-assessed.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the risk management file and instructions of use for the product was completed.Factors and/or some potential probable causes that could include but not limited to abnormal loading of limb, design of device, fit/sizing, patient anatomy, procedural/user error, traumatic injury.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved and no patient medical records, our investigation of this report is inconclusive.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: JOURN ART INS BCS STD 5-6 LT11
• Common Device Name: PRSTHSS, KNEE, PTLLFMRTBL, SM-CNSTRND, CMNTD, PLYMR/MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9801361
• Report Number: 1020279-2020-00813
• Device Sequence Number: 13616545
• Product Code: JWH
• UDI-Device Identifier: 03596010554536
• UDI-Public: 03596010554536
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2020

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: No Information
• Device Expiration Date: 09/28/2018
• Device Model Number: 74024832
• Device Catalogue Number: 74023263
• Device Lot Number: 08JM11745
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 11/15/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 11/20/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 83 YR