MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 5-6 15MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLY/METAL/POLY

Catalog Number	71453224
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Injury (2348)
Date of Event	04/16/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient who was more than three months status post her surgery, failed to regain full range of motion on her right knee.A manipulation under anesthesia was performed and an injection for pain control postoperatively was applied on her right knee.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and based on the information provided, the ¿loss of range of motion¿ experienced by the patient was likely a delayed progression of the post-operative healing phase and not a failure of the smith and nephew device.(b)(4): details regarding the patient¿s weight-bearing status, bone quality, and trauma history have not been provided.Based on the limited information provided and without the return of the device for evaluation the root cause of the reported instability cannot be determined however, during the revision it was found that the patella was tracking laterally and not congruently in the femoral groove ,and this is likely a contributing factor to the instability.The patient impact beyond the revision itself cannot be concluded.(b)(4): based on the information provided, the ¿right knee stiffness¿ experienced by the patient was likely due to the delay in physical therapy following the revision and not a failure of the smith and nephew device.It was reported that ¿she did well postoperatively, though did not perform physical therapy to our satisfaction, partly because of her vertigo and pain issues.¿ no further medical assessment is possible at this time based on the information provided.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 PS HIGH FLEX XLPE SZ 5-6 15MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8155009
• Report Number: 1020279-2018-02751
• Device Sequence Number: 16725587
• Product Code: JWH
• UDI-Device Identifier: 00885556033913
• UDI-Public: 00885556033913
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2019

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: 03/18/2021
• Device Catalogue Number: 71453224
• Device Lot Number: 11CM14011
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 06/06/2019
• 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; Other
• Patient Age: 49 YR