MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II 7.5MM RESUR PAT 26MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIN, CEMENT, POLY/MET/POLY

Catalog Number	71932634
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.(b)(4).
Event or Problem Description
It was reported that, after a tka surgery was performed on (b)(6) 2022, during debridement due to infection, the patella component came off from the patella.The patella component was loosened.This adverse event was treated by a revision surgery on (b)(6) 2022, in which a gen ii 7.5mm resur pat 26mm was exchanged.Patient's current health status is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, it was reported the gen ii 7.5mm resur pat 26mm came off during a debridement procedure due to infection post total knee arthroplasty.The patella component was exchanged in a revision 22 days post implantation.As of the date of this medical investigation, no relevant supporting clinical information has been provided for evaluation.It is noted that further information is unavailable.Therefore, there were no clinical factors found which would have contributed to the reported event.However, it was noted that the customer did not blame the products.The impact to the patient beyond the revision surgery cannot be definitely concluded.No further clinical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.A review of the instructions for use documents for knee systems revealed looseness of components as a result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.It also states that acute post-surgical wound infection, active, local infection or previous intra-articular infections have been identified as possible adverse effects and contraindications for total knee replacement.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.A review of the sterilization records revealed the batch was sterilized within normal parameters.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.Factors that could contribute to the reported event include loss of sterility during procedure, patient reaction, post-operative healing issue, bone degeneration, inadequate integration between the cement and bone/implant and/or osteolysis.Based on this investigation, the need for corrective action is not indicated.Should the device or 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 26MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIN, CEMENT, 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: 16015793
• Report Number: 1020279-2022-04999
• Device Sequence Number: 12588359
• Product Code: JWH
• UDI-Device Identifier: 00885556056233
• UDI-Public: 885556056233
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2023

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 Catalogue Number: 71932634
• Device Lot Number: 21LM05185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 01/17/2023
• Date Device Manufactured: 11/08/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown