MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN OX CONSTRAINED FEM 4 LT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71421164
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/04/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a failed previous total knee arthroplasty.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, (b)(4): without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported cellulitis and hematogenously spread of the acute deep sepsis cannot be confirmed however, based on the reports of multiple surgeries and interventions the reported ongoing infection was the cause for revision and infections as described are not usually a result of product failures or sterility issues of the device.There is no evidence to support our device contributed to the reported infection.(b)(4): the major contributing factor to the reported knee popping is due to a fall the patient sustained and is not due to a mal-performance of the prosthetic components.(b)(4): without the return of the device for evaluation the root cause of the reported failed total knee arthroplasty cannot be concluded.However based on the medical records the patient has sustained multiple falls which cannot be ruled out as contributing factors.The patient impact beyond the revision itself cannot be concluded.No further medical assessment is possible at this time based on the information provided.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches/failure mode.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: LGN OX CONSTRAINED FEM 4 LT
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8348753
• Report Number: 1020279-2019-00665
• Device Sequence Number: 1833387
• Product Code: JWH
• UDI-Device Identifier: 03596010543837
• UDI-Public: 03596010543837
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2019

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 Expiration Date: 07/01/2022
• Device Catalogue Number: 71421164
• Device Lot Number: 12GM01250A
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 02/18/2019
• Supplement Report FDA Received Date: 07/08/2019
• 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
• Patient Age: 72 YR