MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II 7.5MM RESUR PAT 29MM; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Model Number	71932635
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that dislocation and loosening of the patella component were diagnosed.On an unknown date, the patella component was loosening and disassociated.Revision surgery will be performed on (b)(6) 2020.After surgery, the component will be returned.
Additional Manufacturer Narrative
Event description (b5), date implanted (d6) and explanted (d7) received and updated.
Event or Problem Description
It was reported that dislocation and loosening of the patella component were diagnosed.On an unknown date, the patella component was loosening and disassociated.Revision surgery was performed on (b)(6) 2020.
Additional Manufacturer Narrative
Section b5 and d11 were updated.
Event or Problem Description
It was reported that dislocation and loosening of the patella component were diagnosed.On an unknown date, the patella component was loosening and disassociated.Revision surgery was performed on (b)(6) 2020, where patella and insert were revised.
Additional Manufacturer Narrative
The associated devices, used in treatment, were returned and evaluated.A visual inspection of the returned devices could not confirm the stated failure mode.The devices are heavily damaged from wear and extraction.The devices were manufactured in 2018.The medical investigation concluded that ,per the provided x-ray images, a medially mal-tracking patella and possible avascular necrosis of the patella were likely the contributing factors to the reported early failure of the patellar component/patella.Per the product evaluation, the devices were ¿heavily damaged¿.The patient impact beyond the reported findings and revision could not be determined.No further medical assessment is warranted at this time.Should additional clinically relevant documentation be provided, the medical investigation task may be re-evaluated.A dimensional inspection was attempted but the device was too damaged from wear and extraction 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 for this event could include a fit/sizing issue, traumatic injury or abnormal limb loading.Based on this investigation, 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.We consider this investigation closed.

• Brand Name: GEN II 7.5MM RESUR PAT 29MM
• Common Device Name: PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9577202
• Report Number: 1020279-2020-00188
• Device Sequence Number: 2578326
• 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
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/09/2020

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: 71932635
• Device Catalogue Number: 71932635
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 01/21/2020; 02/03/2020; 06/06/2020
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 01/24/2020; 02/27/2020; 06/09/2020
• 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: 74027212,18GM11659,JRII BCS XLPE AR IN SZ 1-2R10MM.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention