MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN XLPE CR INSERT SZ 3-4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71453146
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to the patient (b)(6).Was diagnosed with failed right total knee arthroplasty with instability, this happened four years after her replacement on 2014.Patient was taken to surgery and the polyethylene was removed.A bigger poly size was implanted to solved the instability.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical analysis concluded 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 for the provided batches did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history on the listed parts revealed no prior complaint for the listed batches.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.

• Brand Name: LGN XLPE CR INSERT SZ 3-4 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7980223
• Report Number: 1020279-2018-02213
• Device Sequence Number: 1464087
• Product Code: JWH
• UDI-Device Identifier: 00885556255353
• UDI-Public: 00885556255353
• 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: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2019

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: 11/16/2023
• Device Catalogue Number: 71453146
• Device Lot Number: 13LM12656
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71271440/12DC07340; 71420182/13KT36076; 71420566/13MM10314; 71421225/13MM00338; 71271440/12DC07340; 71420182/13KT36076; 71420566/13MM10314; 71421225/13MM00338
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR