MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II CEMENTED TIBIAL B/PLATE SZ3 RIGHT; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLY}METAL}POLY

Catalog Number	71420182
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	07/25/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient started with erythema swelling suprapatellar area for 2 weeks.She was complained of pain due to cellulitis.The patient had pain stiffness and failed post attempts and manipulation of the right knee.She was admitted for iv vancomycin administration for suspected deep joint prosthetic infection.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.A review of the complaint history for the listed parts revealed no prior complaints for the listed batches.A review of the manufacturing or product specifications did not reveal any abnormalities that could have contributed to the reported issue.Product was sterilized according to sterilization release documentation from quality control.Our clinical/medical team concluded:although it is unknown if the patient¿s immune disorder and comorbidities contributed to the abundant scar tissue/arthrofibrosis for which the mua was performed, arthrofibrosis is a known occurrence and possible complication post tka and not a failure of the prosthesis.There was insufficient supporting documentation of the reported cellulitis and antibiotic therapy; however, based on the lab results the reported erythema and suprapatellar swelling could have been secondary to the mua or other factors but not likely a result of the well-fixed prosthesis or a deep joint infection.The root cause of the gross instability secondary to medial-lateral ligament laxity for which the right tka revision was required cannot be concluded; however, the loss to follow up for approximately 2 years likely contributed to worsening symptoms and a prosthetic malfunction was not supported.The patient impact beyond the reported interventions, revision surgery, and expected post-procedural rehab cannot be concluded.No further medical assessment can be rendered at this time.Without the actual product involved, 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.

• Brand Name: GEN II CEMENTED TIBIAL B/PLATE SZ3 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: 8205225
• Report Number: 1020279-2018-02945
• Device Sequence Number: 18880752
• Product Code: JWH
• UDI-Device Identifier: 03596010206336
• UDI-Public: 03596010206336
• 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: 2014
• 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: 10/24/2023
• Device Catalogue Number: 71420182
• Device Lot Number: 13KT36076
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 12/28/2018
• 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: 55 YR