MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JII UNI TIB XLPE INS SZ 5-6 8MM RM/LL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71935225
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery was performed on (b)(6) 2021, the patient experienced pain due to a premature polyethylene wear following implantation of prosthesis medial monocompartimental right knee.This adverse event was treated by a revision surgery on (b)(6) 2023, in which a jii uni tib xlpe ins sz 5-6 8mm rm/ll was exchanged.Patient's current health status is unknown.
Additional Manufacturer Narrative
Internal complaint reference:(b)(4).
Event or Problem Description
It was reported that, after a right medial uka surgery was performed on (b)(6) 2021, the patient experienced pain due to a premature polyethylene wear following implantation of prosthesis.This adverse event was treated by a revision surgery on (b)(6) 2023, in which a jii uni tib xlpe ins sz 5-6 8mm rm/ll was exchanged.Patient's current health status is unknown.
Additional Manufacturer Narrative
Section h10: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, approximately 1.5 years post unicompartmental knee arthroplasty, the patient had a revision due to pain.It is reported the pain was due to premature poly wear.However, as of the date of this medical investigation, the requested clinical documentation has not been provided for evaluation.Therefore, there were no clinical factors found which would have contributed to the reported event.The patient's current condition is unknown and the patient impact beyond the revision surgery could not be determined.No further clinical assessment can be rendered at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed that wear of the polyethylene articulating surfaces of knee replacement components has been previously reported.Higher rates of wear may be initiated by particles of cement, metal, or other debris which can cause abrasion of the articulating surfaces.Higher rates of wear may shorten the useful life of the prosthesis and lead to early revision surgery to replace the worn prosthetic components, this has been identified as possible adverse effects.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.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include friction or joint tightness.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.Internal complaint reference number: (b)(4).

• Brand Name: JII UNI TIB XLPE INS SZ 5-6 8MM RM/LL
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 16771347
• Report Number: 1020279-2023-00872
• Device Sequence Number: 3237777
• Product Code: HSX
• UDI-Device Identifier: 00885556579046
• UDI-Public: 00885556579046
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K152315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

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: 71935225
• Device Catalogue Number: 71935225
• Device Lot Number: 19HAP0074B
• 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: 03/24/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Unknown