MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK GD MOTION ISRT 11MM SZ 2-3 LT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71423341
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	01/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after primary tkr, the patient presented a prosthetic joint infection, and underwent to a revision surgery to perform a washout and a poly exchange.The legion hk gd motion insert 11mm sz 2-3 left (b)(4) was explanted, as well as the legion hk 11mm bolt - sleeve (b)(4) since it was reported that the sleeve of the hinge prosthesis which holds the bolt anti-rotational part broke off, causing the sleeve to rotate.The patient is currently mobilizing adequately asymptomatic.Additional details have not been provided at this time.
Additional Manufacturer Narrative
H6: the devices, used in treatment, were returned for evaluation.A lab analysis was performed and confirms the components were inspected visually to determine the cause of the reported incident.No destructive analysis was conducted during this investigation.The insert, bolt, and sleeve were retrieved.Damage is present in the middle hole of the insert and on the articulating surface of the insert.The bolt and sleeve did not show any damage.There were no observations of material or manufacturing deviations in the course of this investigation.A medical investigation was conducted and confirms this case reports that a revision was performed to explant a broken legion hinge bolt sleeve.The implantation date is unknown, and without responses to the documentation/information requests, the clinical root cause of the reported event cannot be determined.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Infection, a potential complication associated with any surgery, can occur and possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: LEGION HK GD MOTION ISRT 11MM SZ 2-3 LT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11478925
• Report Number: 1020279-2021-02084
• Device Sequence Number: 3625367
• Product Code: KRO
• UDI-Device Identifier: 00885556031087
• UDI-Public: 00885556031087
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71423341
• Device Catalogue Number: 71423341
• Device Lot Number: 02KM05356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 03/14/2021
• Supplement Report FDA Received Date: 07/29/2021
• 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; Other; Required Intervention