MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II 7.5MM RESUR PAT 35MM; POSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL

Model Number	71932637
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported revision surgery was performed due to disassociation of the patella component.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.Only the patella was returned for evaluation.A visual inspection of the returned device could not confirm the stated failure mode.The device has signs of damage/ deformation from implantation.The device also had cement stuck in the cavity between the posts.The device was manufactured in 2018.The medical investigation concluded that, without the requested clinical information, a thorough medical investigation cannot be rendered.Should any additional clinical information be provided this complaint will be re-evaluated.A dimensional inspection was attempted but the device was too damaged from implantation to obtain accurate measurements.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes of this event could include abnormal loading or improper sizing.The need for corrective action is not indicated.Should 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: GEN II 7.5MM RESUR PAT 35MM
• Common Device Name: POSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9559444
• Report Number: 1020279-2020-00154
• Device Sequence Number: 2238046
• Product Code: JWH
• UDI-Device Identifier: 00885556057117
• UDI-Public: 00885556057117
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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: 71932637
• Device Catalogue Number: 71932637
• Device Lot Number: 18MM14062
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 03/03/2020
• 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: PART # 74022126PART # 74027261PART # 74022225; PART # 74022126PART # 74027261PART # 74022225
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR