MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 7-8 RT 9; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74023271
Medical Device Problem Codes	Break (1069); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, in order to alleviate patella pain, a revision surgery was performed.The surgeon make a resurfacing of the patella and put a patellar implant.Also, on the day of the surgery, the surgeon decided to exchange the journ art ins bcs std 7-8 rt 9 due to it was found broken when the knee was exposed.No apparent health consequences were reported.
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 patient underwent a patella resurfacing along with a poly-insert revision approximately 11.5 years post tka due to pain.It was communicated that ¿once knee was exposed surgeon noticed that the post of the poly had broken and had to exchange the poly¿.The time of post-breakage is unknown.Per correspondence, no further information is available.Without the requested clinical documentation, the root cause of the reported fractured poly insert-post could not be fully assessed or concluded.The patellar resurfacing is not indicative of a component mal-performance, but instead, likely due to disease progression.The patient impact beyond the reported resurfacing after approximately 11.5 years, the fractured post and insert revision could not be determined.No further medical investigation could be rendered at this time.Should clinically relevant documentation/ information become available, the clinical/medical task may be re-evaluated.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.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, excessive forces applied to implant or patient reaction.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.

• Brand Name: JOURN ART INS BCS STD 7-8 RT 9
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12331621
• Report Number: 1020279-2021-06410
• Device Sequence Number: 16845682
• Product Code: JWH
• UDI-Device Identifier: 03596010555274
• UDI-Public: 03596010555274
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

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 Model Number: 74023271
• Device Catalogue Number: 74023271
• Device Lot Number: 08GM07733
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 10/27/2021
• 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