MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JII UNI TIB BASE SZ 2 LM/RL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71935194
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	09/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, on (b)(6) 2020 the patient had 11 degrees of varus knee alignment which was corrected to neutral during ukr of medial compartment on (b)(6) 2020.On (b)(6) 2020, patient presented pain in the lateral knee compartment.Therefore, on (b)(6) 2020 the patient had a uka of the lateral compartment.The pre-operative and 3 months post-operative radiographic evaluation could possibly explain the overloading of lateral compartment and subsequent need for additional ukr on the lateral side.On (b)(6) 2021, the patient following implantation of an additional uni knee prosthesis into the same knee, experienced loosening of the initial (medial) uni knee tibial component.Therefore, on (b)(6) 2021 the patient had another revision surgery where both uni knees were explanted and a tka was implanted.The explants are not available for analysis, nor operative reports and x-rays yet.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, a review of the documents provided did not provide any insight into the root cause of the reported events.The requested x-ray/ mri images were not provided for review.Per the provided adverse event form the patient is "recovering" following the revision.Based on the limited information provided a thorough medical assessment could not be performed.Should additional information be provided, the clinical/medical investigation task will be re-opened for further evaluation.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing issue, lack of ingrowth, lifetime of device, and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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: JII UNI TIB BASE SZ 2 LM/RL
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12101254
• Report Number: 1020279-2021-05599
• Device Sequence Number: 14395065
• Product Code: HSX
• UDI-Device Identifier: 00885556578735
• UDI-Public: 00885556578735
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2021

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 Model Number: 71935194
• Device Catalogue Number: 71935194
• Device Lot Number: 19DAP0189B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 08/22/2021
• 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