MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK 15MM BOLT - SLEEVE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71421387
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to pain and instability.Bolt and sleeve were removed in order to reposition the components, hinge femoral and tibial components were cemented in situ.Once the components were removed, it was noticed that the sleeve was bent, attempting to straighten the hinge, sleeve tab broke completely off.There was no backup or replacement available; surgeon implanted the broken sleeve again using forceps.Hinge bolt successfully inserted and tightened.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to pain and instability.The affected legion bolt-sleeve, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.Potential causes could include but not limited to patient anatomy or abnormal loading of limb.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Without the return of the device involved and no patient records available, our investigation is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, this complaint will be reopened and reevaluated.

• Brand Name: LEGION HK 15MM BOLT - SLEEVE
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9137585
• Report Number: 1020279-2019-03514
• Device Sequence Number: 19528578
• Product Code: KRO
• UDI-Device Identifier: 00885556030004
• UDI-Public: 00885556030004
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2020

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: Health Professional
• Device Model Number: 71421387
• Device Catalogue Number: 71421387
• Device Lot Number: 18ATM0007K
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 01/23/2020
• 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