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	Injury (2348); Fibrosis (3167)
Date of Event	06/02/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a right knee closed manipulation under anesthesia was performed to the patient due to arthrofibrosis, status post total knee arthroplasty.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical analysis indicated that 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.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history on the listed part revealed no prior complaints for the listed batch.Without the actual product involved our investigation cannot proceed.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.If the devices are received in the future, this complaint can be re-opened.We consider this complaint closed.

• 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: 8205227
• Report Number: 1020279-2018-02941
• Device Sequence Number: 11198927
• 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): 06/10/2019

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: 06/10/2019
• 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