MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 5-6 18; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER

Model Number	71421519
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Metal Related Pathology (4530)
Date of Event	11/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, after a left tka surgery had been performed on (b)(6) 2014, the patient reported ongoing pain.Patient was sent for a bone scan that showed an area of concern medially under the tibial baseplate.This adverse event was addressed by a revision surgery on (b)(6) 2021, in which it was found that the tissues had the typical appearance of metallosis, with inflamed synovium and fluid collection.Tissue samples and retrieved implants were sent for pathology testing.Visual inspection of implants showed wear on the posterior side of the gii ps hi flex isrt sz 5-6 18.Nil wear was visible to gii nonporous p/s fem sz 6 lt nor gns ii cmt tib size 6 left.The condition of the patient is unknown.
Additional Manufacturer Narrative
The device was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that, based on the documentation provided, the root cause of the reported pain and 1st revision could not be definitively concluded; it was not reported in the information if there were findings consistent with loosening of the tibial component.The 6 months between symptom onset and revision could have been a contributing factor to the severity of the symptoms and intra-operative findings of ¿inflamed synovium and fluid collection¿.Reportedly, there was ¿nil¿ wear visually to the femoral or tibial components.No pathology results were available and based on the documentation provided, a diagnosis of ¿metallosis¿ could not be confirmed.The assessed patient impact was the ps insert post wear and 1st revision secondary to pain and concerning ct findings.Further patient impact could not be assessed.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 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 risk management file and instructions for use documents 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 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 overuse or excessive pressure on the joint, injury, infection and/or patient condition.The contribution of the device to the reported event could not be corroborated.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: GII PS HI FLEX ISRT SZ 5-6 18
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER
• 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: 12875261
• Report Number: 1020279-2021-08402
• Device Sequence Number: 19993250
• Product Code: JWH
• UDI-Device Identifier: 03596010493835
• UDI-Public: 03596010493835
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2022

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 Model Number: 71421519
• Device Catalogue Number: 71421519
• Device Lot Number: 07AT05680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 11/25/2021
• Supplement Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: A
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male