MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II CEMENTED TIBIAL B/PLATE SZ2 RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Catalog Number	71420180
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed.The tibia had to be removed.
Additional Manufacturer Narrative
The associated devices were returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The femoral component had little bone /bone cement adhered to the surface and had scratches and discoloration on the articular surface.The tibial insert had wear on the articular surface and scratches on the anterior side.The tibial baseplate had a significant amount of bone/ bone cement adhered to the surface and scratching on the superior side.The devices were manufactured in 2013.A review of complaint history did not reveal additional complaints for the listed batches for the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The clinical / medical investigation concluded that the two x-rays provided show extreme bone resorption around the femoral component and loosening, in addition to the product evaluation which confirms the reported wear.It is unknown the root cause for the bone resorption however, we cannot rule out the reported articulation of the prosthesis or the patient body habitus (weight unknown) as contributing factors.The future impact to the patient beyond the revision cannot be concluded.No further clinical/medical assessment is warranted at this time.Based on this investigation, the need for corrective action is not indicated.Should 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: GEN II CEMENTED TIBIAL B/PLATE SZ2 RIGHT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8092364
• Report Number: 1020279-2018-02541
• Device Sequence Number: 13792757
• Product Code: JWH
• UDI-Device Identifier: 03596010206329
• UDI-Public: 03596010206329
• Combination Product (Y/N): N
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2019

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: 71420180
• Device Lot Number: 13ET30787
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 05/21/2019
• 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