MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII NONPOROUS P/S FEM SZ 4 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	71420102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that a revision surgery of gen ii was performed due to an unspecified reason.Patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
It was reported that a revision surgery of gen ii was performed due to an unspecified reason.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of manufacturing records did not reveal any deviation from the standard manufacturing processes.A review of the complaint history on the listed part revealed no prior complaints with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.Based on this investigation, the need for corrective action is not indicated.The device was sterilized according to sterilization release documentation from quality control.A review of risk management files and the instructions for use cannot be performed with accuracy as the reason for reported failure was unknown.Therefore no root cause can be determined at this time.A medical analysis noted that the single unidentified x-ray provided appears to show radiolucency under the anterior tibial base plate and appears continuous with the radiolucency anterior of tibial post with possible infection/inflammation, cystic, or even a neoplastic formation judging by the bulging of the anterior cortex.The joint space appears narrowed so there may be some reaction if there is poly wear; however, comparison images were not provided for evaluation.It does appear that the patella remains un-resurfaced in this image.It was communicated that no further clinical documentation would be provided due to lack of consent.No further clinically relevant information was provided for inclusion in the medical investigation.Without the patient medical records available and no reported device failure, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we 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 NONPOROUS P/S FEM SZ 4 LT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11018667
• Report Number: 1020279-2020-07511
• Device Sequence Number: 4495815
• Product Code: JWH
• UDI-Device Identifier: 03596010205957
• UDI-Public: 03596010205957
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/21/2023
• Device Model Number: 71420102
• Device Catalogue Number: 71420102
• Device Lot Number: 13JM14730
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 03/17/2021
• 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; Required Intervention