MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II 7.5MM RESUR PAT 29MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71932635
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after procedure, the patient's patella fractured during rehabilitation.Adverse event treated with a cast, no procedure has been scheduled.
Additional Manufacturer Narrative
A clinical evaluation was conducted and the x rays provided show the placement with the resurfacing component being anterior to the central location of the patella.Trauma cannot be ruled out as a cause to the fracture.Based on the limited information provided and without the return of the device for evaluation the root cause of the reported patella fractured cannot be confirmed.However an injury during rehabilitation cannot be ruled out.The future impact to the patient cannot be determined.Should additional information becomes available this issue can be re elevated.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with 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.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.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Reviewed during mimb.A medical investigation will be performed.Proceed based on information provided and/or available for the investigation; if no relevant clinical information is provided, recommend closure.Approved by dr.(b)(6) and/or (b)(6), medical director.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: patient information.Surgical procedure/post-operative care review.Device labeling (including technique guides, ifus, etc.) this case reports that following a right tka procedure the patient's patella fractured during rehabilitation.The fracture was treated with a cast and no procedure has been scheduled.Two x-ray photos taken a month following the tka procedure were provided for review and confirm the broken patella.It is noted that the patella button is not centralized.This could be related to trauma.Details regarding the patient¿s weight-bearing status, medical history, bone quality, fall/trauma history, and other additional clinical relevant information have not been provided.Conclusion: the x-rays provided show the placement with the resurfacing component being anterior to the central location of the patella.Trauma cannot be ruled out as a cause to the fracture.Based on the limited information provided and without the return of the device for evaluation the root cause of the reported patella fractured cannot be confirmed.However an injury during rehabilitation cannot be ruled out.The future impact to the patient cannot be determined.Should additional information becomes available this issue can be re-elevated.Conclusion: the x-rays provided show the placement with the resurfacing component being anterior to the central location of the patella.Trauma cannot be ruled out as a cause to the fracture.Based on the limited information provided and without the return of the device for evaluation the root cause of the reported patella fractured cannot be confirmed.However an injury during rehabilitation cannot be ruled out.The future impact to the patient cannot be determined.Should additional information becomes available this issue can be re-elevated.

• Brand Name: GEN II 7.5MM RESUR PAT 29MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8359911
• Report Number: 1020279-2019-00740
• Device Sequence Number: 16678675
• Product Code: JWH
• UDI-Device Identifier: 00885556056516
• UDI-Public: 00885556056516
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71932635
• Device Lot Number: 18HM17446
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 06/15/2019
• 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