MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHEM CR HF INSERT SZ 7-8 9MM; PROSTHESIS, KNEE, PATFEMTIB, SEMI-CONSTRAIND, CEMENTD, POLY/METAL/POLY

Model Number	71422977
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent revision surgery due to complains of soreness and stiffness.The surgeon explanted the femoral component and downsized it from an anthem cr size 8 to a legion ps size 7 and also replaced the insert from a cr 9mm to a ps 11mm.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the patient underwent a revision surgery due to soreness and stiffness.Per email communication, the requested surgical report and x-rays are not available.Therefore, the patient impact beyond the revision cannot be determined.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 the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes could be alignment, fit/size of device used or wear.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, 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: ANTHEM CR HF INSERT SZ 7-8 9MM
• Common Device Name: PROSTHESIS, KNEE, PATFEMTIB, SEMI-CONSTRAIND, CEMENTD, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10781784
• Report Number: 1020279-2020-06097
• Device Sequence Number: 3773589
• Product Code: JWH
• UDI-Device Identifier: 00885556656112
• UDI-Public: 00885556656112
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K170648
• 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): 07/22/2021

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: 71422977
• Device Catalogue Number: 71422977
• Device Lot Number: 17CM17652
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 07/22/2021
• 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: 71420578, LOT: 19HM17606; 71422847, LOT: 16DM18602
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention