MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN REV TIBIA BASE SZ 5 RT; PROSTHESIS, KNEE, PATFEMOROTIBIAL, SEM-CONSTRAIN, CEMNT, PLYMR/MET/PLYMR

Catalog Number	71424015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Limited Mobility Of The Implanted Joint (2671)
Date of Event	05/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an arthroscopy was performed due to poor range of motion.Significant soft tissue was removed.Good range of motion at the end of the surgery.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that, it was communicated that explanted devices were unknown and no consent had been obtained; therefore, clinically relevant documentation was not provided.Per complaint details, an arthroscopy (possible revision) was performed approximately 2 years post implantation on a well-fixed knee due to poor rom secondary to incomplete rehab (severe burns).Reportedly, although the arthroscopic release with significant soft tissue removal resulted in good rom on the table, only minimum results were achieved post-operatively.It was unclear if component revision was performed at that time.In conclusion: reportedly the ¿poor rom¿ secondary to incomplete rehab/severe burns was the root cause of the arthroscopy/revision.The patient impact beyond the reported symptoms and subsequent arthroscopy/revision could not be determined.Although the complaint indicated there was good rom on the table, the actual procedure achieved only ¿minimum results¿ post-operatively per complaint/ response.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.No further medical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed device.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes could be alignment, fit/size of device used or wear.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.G1 mdr reporting contact name and address and phone number.

• Brand Name: LGN REV TIBIA BASE SZ 5 RT
• Common Device Name: PROSTHESIS, KNEE, PATFEMOROTIBIAL, SEM-CONSTRAIN, CEMNT, PLYMR/MET/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10110037
• Report Number: 1020279-2020-01937
• Device Sequence Number: 14233634
• Product Code: JWH
• UDI-Device Identifier: 03596010546173
• UDI-Public: 3596010546173
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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 Catalogue Number: 71424015
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2020
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 06/28/2021
• 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; Required Intervention