MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN OFFSET COUPLER 4MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIN, CEMNT, PLYMR/MET/PLYMR

Model Number	71424225
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
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms 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 the risk management file revealed this failure mode was previously identified.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.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.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: LGN OFFSET COUPLER 4MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIN, CEMNT, PLYMR/MET/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10110877
• Report Number: 1020279-2020-01940
• Device Sequence Number: 19663386
• Product Code: JWH
• UDI-Device Identifier: 03596010547132
• UDI-Public: 03596010547132
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K043440
• 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): 06/16/2021

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: 71424225
• Device Catalogue Number: 71424225
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 05/06/2020
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 06/16/2021
• 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