MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II COCR PS NP FEMORAL COMP SZ 2 LEFT; PROSTHE, KNEE, PATELLOFEM, SEMI-CONS, CEMENTED, POLY/METAL/POLY

Catalog Number	71420098
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a new knee surgery was performed on (b)(6) 2018 where it was detected that a part of the femoral component of the implanted knee prosthesis was broken.The first surgery was performed at the same hospital, with another doctor in 2012.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A dimensional inspection was attempted; the damage/deformation at several features of the device would not allow for accurate measurement.The feature of thickness, which may have potentially affected strength was measured and was within specification.A lab analysis indicated that the conversion module fractured in between the paddles that contact the femoral component.A piece of the conversion module is still adhered to the femoral component with bone cement and a lug still attached.The other part of the module has fractured off and is still attached to the stem.The articulating surface and sides of the femoral component are scratched.The lug on the side where the module is still adhered to the implant is intact with some damage, but the other lug has been sheared off.The stem of the conversion module shows wear.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 for the listed parts did not reveal additional complaints for the listed parts or batches.A clinical analysis indicated that no clinical relevant supporting documents were provided to conduct a thorough analysis of the reported event.Photos of the broken device were provided.However, no radiographic images or operative reports have been provided.It was further reported all broken pieces were successfully removed from the patient.No further clinical assessment is warranted.Based on this investigation, the need for corrective action is not indicated.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: GEN II COCR PS NP FEMORAL COMP SZ 2 LEFT
• Common Device Name: PROSTHE, KNEE, PATELLOFEM, SEMI-CONS, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8305438
• Report Number: 1020279-2019-00442
• Device Sequence Number: 46669
• Product Code: JWH
• UDI-Device Identifier: 03596010208415
• UDI-Public: 03596010208415
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2019

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: 01/13/2019
• Device Catalogue Number: 71420098
• Device Lot Number: 09AM12038
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 10/07/2019
• 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: 71420598 / 10CM04330
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 63