MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTICULAR SURFACE SIZE 6 8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	00584202608
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that a revision surgery took place on (b)(6) 2021, due to an infection in the patient knee.The concern is the significant amount of wear the articular surface size 6 8mm shows from the short amount of time it was implanted.Primary surgery took place on (b)(6) 2021.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode of infection.The visual inspection did confirm the device has extensive wear on the articular surface and is damaged from extraction.The clinical medical investigation concluded that this case reports that a revision/poly exchange surgery was performed 25 days post implantation, due to infection.Per email correspondence, the patient was treated for an infection and the insert was removed for standard practice of an incision and drainage procedure.Additionally, the requested surgical records and x-rays have not been provided.Therefore, the patient impact beyond the revision and the clinical root cause of the infection cannot be determined.Due to the limited information provided, no further clinical assessment can be rendered at this time.Should additional clinically relevant documentation become available, the clinical/medical task may be re-opened.A review of complaint history did not reveal additional complaints for the listed batch.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.A review of the sterilization records revealed the batch was sterilized within normal parameters.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes for this event could include traumatic injury, patient reaction or a post-operative healing issue.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.

• Brand Name: ARTICULAR SURFACE SIZE 6 8MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11479296
• Report Number: 1020279-2021-02135
• Device Sequence Number: 3625297
• Product Code: HSX
• UDI-Device Identifier: 00885556620274
• UDI-Public: 00885556620274
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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 Model Number: 00584202608
• Device Catalogue Number: 00584202608
• Device Lot Number: 63331143D16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2021
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 00584200601/TIB BASE SZ 6 LM/RL/63506393; 00584201501/FEMORAL SIZE E LM/RL/64061998; 00584200601/TIB BASE SZ 6 LM/RL/63506393; 00584201501/FEMORAL SIZE E LM/RL/64061998
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention