MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII C/R HA POROUS FEM SZ 7LT; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Catalog Number	71422050
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed on the patient and metallosis was found as the cause of pain.No infection present.Two devices reported.No additional details available.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed on the patient and metallosis was found as the cause of pain.No infection was present.The associated genesis ii c/r articular insert, genesis ii c/r porous femoral component and genesis ii cmt tibia baseplate were returned and evaluated.A lab analysis conducted during this investigation indicated that the articulating surface of the insert is discolored and has scratches present.Scratches are also observed on the bone cement contacting surface, the proximal surface and the locking detail of the baseplate.Some bone cement still adhered to it.The non-articulating surface of the femoral implant has traces of apparent bone still adhered to it.The articulating surface and sides of the femoral component are scratched and worn.The clinical analysis noted that without clinical documents, labs report, metal ions or operative notes the reported metallosis cannot be confirmed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Without the return of the actual product involved and based on the limited information provided, our investigation of this report is inconclusive.No further investigation warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GII C/R HA POROUS FEM SZ 7LT
• Common Device Name: PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8448818
• Report Number: 1020279-2019-01165
• Device Sequence Number: 11484778
• Product Code: MBH
• UDI-Device Identifier: 03596010496324
• UDI-Public: 03596010496324
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K030612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2019

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: 71422050
• Device Lot Number: 09DM05061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 11/25/2019
• 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