MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII DISHED INS SZ 5-6 13MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420782
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a revision of a patella component referenced in another complaint form, the surgeon chose to exchange the poly as well.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.The lab analysis concluded, the as received tibial insert showed damage inside and around the insertion extraction slot.Damage and deformation was observed on the articular surface of the insert; these features have been reported as being created by third-body particulate (bone cement, bone, etc.) in the joint space.Cement and bone particulate are known to be produced during a total knee arthroplasty (tka), even under carefully controlled conditions.No material or manufacturing defects were observed in the course of this investigation.The clinical/medical team concluded, based on the complaint description, the root cause of the patellar loosening and subsequent revision was the reported patient fall, which could also explain the two missing patellar pegs.It was reported that the surgeon elected to proceed with revision of the tibial insert which is routinely performed once the knee is opened for any procedure.No further patient impact is anticipated beyond the revision procedure itself and a brief post-surgical rehabilitation phase.No further medical assessment can be rendered at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: GII DISHED INS SZ 5-6 13MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8213381
• Report Number: 1020279-2019-00028
• Device Sequence Number: 1850616
• Product Code: JWH
• UDI-Device Identifier: 03596010209405
• UDI-Public: 03596010209405
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2019

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 Catalogue Number: 71420782
• Device Lot Number: 11AM00485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2018
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 04/05/2019
• 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; Required Intervention