MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS OXIN FEM SZ6 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIND, CEMENTD, POLY/METAL/POLY

Model Number	71421216
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the surgeon has booked this patient for a revision of her knee replacement, taking place the (b)(6) 2020.The motive of this revision surgery is unknown.
Additional Manufacturer Narrative
H6: the device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms this case reports that a revision was scheduled to be performed for an "unspecified adverse event." to date, it is unknown whether the revision has been performed, and the requested x-rays and surgical reports have not been provided.Therefore, due to the limited information provided, no further clinical assessment is warranted.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 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.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: LEGION PS OXIN FEM SZ6 LT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIND, CEMENTD, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10911768
• Report Number: 1020279-2020-06791
• Device Sequence Number: 3317098
• Product Code: JWH
• UDI-Device Identifier: 00885556030059
• UDI-Public: 00885556030059
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

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: 02/19/2023
• Device Model Number: 71421216
• Device Catalogue Number: 71421216
• Device Lot Number: 13BM12692
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 07/20/2021
• 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: INSERT 71421519, LOT 15HM00570.; TIB BASE PLATE 71420168, LOT 16CM1120.