MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN ZUK UNI KNEE IMPL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNKN01200500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)

Event Date 09/15/2020

Event Type  Injury  

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.(b)(4).

Event Description

It was reported that, after a left high flex unicondylar knee replacement had been performed on (b)(6) 2020, the patient experienced pain, swelling, and stiffness immediately post-op.There has not been any improvement in pre-op symptoms with progression over time.Patient has been treated with systemic nsaids, systemic glucocorticoids, leflunomide, and adalimumab.The event is ongoing.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, immediately post-op left hf uni-knee replacement performed on (b)(6) 2020, the patient ¿with no comorbidities¿ experienced ¿no improvement in pre-op symptoms with progression over time, pain, swelling and stiffness¿.Reportedly, the patient has been treated with systemic nsaids, systemic glucocorticoids, leflunomide, and adalimumab without resolution.It is unknown if the patient has a pre-existing and/or undiagnosed allergy to one or more of the implanted biomaterials.As of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, no clinical factors could be confirmed to have contributed to the reported event.The patient impact beyond that which was reported could not be determined.No further medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction, fit/size of device used or wear.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKN ZUK UNI KNEE IMPL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15272320
• MDR Text Key: 298378619
• Report Number: 1020279-2022-03786
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/26/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01200500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2022
• Initial Date FDA Received: 08/22/2022
• Supplement Dates Manufacturer Received: 08/25/2022
• Supplement Dates FDA Received: 08/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 76 KG