MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OXINIUM FEM SIZE 4 LEFT; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	71420134
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a chronic infection it was decided to explanted the implants, gii oxinium fem size 4 left, gns ii cmt tib size 5 left and lgn xlpe dished isrt sz 5-6 9mm.Site was washed out.Once wound was opened samples were taken and sent to histology.A cocr genii femur and all poly tibia was implanted.Patient outcome is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that per complaint details, the revision was performed due to an unspecified chronic infection.It was communicated that the requested medical documentation was not available for evaluation and the explanted components were not returning.¿the surgeon does not blame the implants for the issue¿.The root cause of the reported chronic infection remains unknown.The patient impact beyond the reported infection and subsequent revision could not be determined.No further medical assessment could be rendered at this time.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal any manufacturing or material abnormalities 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.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.A review of sterilization documents indicated that the product was sterilized according to sterilization release documentation.Infection, a potential complication associated with any surgery, can occur and possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, 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: GII OXINIUM FEM SIZE 4 LEFT
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11449977
• Report Number: 1020279-2021-01949
• Device Sequence Number: 3513548
• Product Code: LZO
• UDI-Device Identifier: 03596010430144
• UDI-Public: 03596010430144
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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: 03/05/2021
• Device Model Number: 71420134
• Device Catalogue Number: 71420134
• Device Lot Number: 11CM15562
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 07/01/2021
• 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; Other; Required Intervention