MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II RESURF PATELLA 38MM; PROST, KNEE, PATFEMTIB, SEMI-CNSTRND, CMNTD, POLY/MET/POLY

Model Number	71926225
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after surgery had been performed on (b)(6) 2020, the patient experienced a loose patella.This adverse event was solved with a revision surgery on (b)(6) 2022.The current health status of patient is unknown.
Additional Manufacturer Narrative
H10: h3, h6: the associated device was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.The device showed the presence of hardened bone cement within the three pegs.The device was found to be worn and slightly deformed along its surface likely from extraction and/or use within the patient.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.The clinical/medical evaluation concluded that subsequent e-mail, no relevant supporting clinical documentation will be provided for inclusion in this medical investigation.Therefore, a thorough medical investigation could not be rendered, nor could the clinical root cause of the reported loosening be determined.Based on the information provided, a revision was performed as treatment to this adverse event.The impact to the patient beyond that which has been reported cannot be confirmed nor concluded.Should any additional relevant medical information be provided, this case would be re-assessed.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 document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.The contribution of the device to the reported event could not be corroborated.Factors and/or some potential probable causes that could contribute to the reported event have been identified as but not limited to abnormal motion over time, bone degeneration, design of device, fit/sizing, lack of ingrowth, and traumatic injury.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 future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GEN II RESURF PATELLA 38MM
• Common Device Name: PROST, KNEE, PATFEMTIB, SEMI-CNSTRND, CMNTD, POLY/MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14947086
• Report Number: 1020279-2022-03252
• Device Sequence Number: 6148145
• Product Code: JWH
• UDI-Device Identifier: 00885556043998
• UDI-Public: 00885556043998
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2022

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: 71926225
• Device Catalogue Number: 71926225
• Device Lot Number: 19LM10234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 08/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male