MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 6 RIGHT; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLY/METAL/POLY

Catalog Number	71420188
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Neck Stiffness (2434)
Date of Event	06/01/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient was diagnosed with right knee stiffness status post revision, and right knee replacement.A manipulation under anesthesia and an injection of pain cocktail containing toradol, morphine, epinephrine and bupivacaine, in periarticular tissues and intra-articularly were performed.
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: GNS II CMT TIB SIZE 6 RIGHT
• 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: 8155611
• Report Number: 1020279-2018-02758
• Device Sequence Number: 16210300
• Product Code: JWH
• UDI-Device Identifier: 03596010206367
• UDI-Public: 03596010206367
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• 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): 06/05/2019

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: 11/24/2021
• Device Catalogue Number: 71420188
• Device Lot Number: 11LT12518
• 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: 06/05/2019
• 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: 51 YR