MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II CEMENTED TIBIAL B/PLATE SZ 8 LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Catalog Number	71420174
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	11/15/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a medial intervention was performed.Complete bilateral lower extremity ultrasound examination due to pain and edema was performed.No evidence of chronic or deep venous thrombosis.
Additional Manufacturer Narrative
The associated genesis ii np tibial baseplate and legion ps np femoral component were not returned for evaluation.A clinical analysis noted that based on ultrasound finding and with limited information provided, the root cause of the bilateral lower extremity pain and edema cannot be determined.It is unknown if the patient is still experiencing these symptoms or if any medical interventions have been performed to alleviate or treat the reported issues.The impact to the patient beyond these symptoms cannot be concluded.No further clinical/medical assessment is warranted at this time.Our investigation included a review of complaint history for the listed parts which revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batches which did not reveal any deviation from the standard manufacturing processes.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: GEN II CEMENTED TIBIAL B/PLATE SZ 8 LEFT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8146793
• Report Number: 1020279-2018-02730
• Device Sequence Number: 13812271
• Product Code: JWH
• UDI-Device Identifier: 03596010206305
• UDI-Public: 03596010206305
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 02/22/2021
• Device Catalogue Number: 71420174
• Device Lot Number: 11BM16080
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR