MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHEM FEMORAL CR COCR SZ 5 RT N; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71422945
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Osteolysis (2377); Radiolucent Lines (4848)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after right tka surgery that was performed on (b)(6) 2023, the patient presented femoral radiolucencies on (b)(6) 2024.In addition, the clinical study identified osteolysis on the femoral component.It is unknown how this event was treated.Current outcome is unresolved.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about a specific product problem.The reported complication relates to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
H3, h6: although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the femoral component.The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that as of the date of this medical investigation the clinical report forms only were provided for review.Therefore, a thorough medical investigation could not be rendered, nor could the definitive clinical root cause of the reported adverse event be determined.According to the report, this adverse event is classified as an adverse device effect, not related to the study device, and not related to the procedure.The report stated in addition the study identified osteolysis on the femoral component.However, without supporting clinical documentation this cannot be confirmed.The impact to the patient beyond that which has already reported cannot be determined since it is unknown how this adverse event was treated, and the patient¿s outcome is unknown.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 total hip systems revealed in adverse events in primary and revision surgery that with all joint replacements, asymptomatic, localized, progressive bone resorption (osteolysis) may occur around the prosthetic components as a consequence of foreign body reaction to particulate wear debris.Osteolysis can lead to future complications necessitating the removal or replacement of prosthetic components.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.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal motion over time, bone degeneration, patient condition, traumatic injury, patient medical history, adverse reaction and/or bone quality.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: ANTHEM FEMORAL CR COCR SZ 5 RT N
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 19968001
• Report Number: 1020279-2024-01574
• Device Sequence Number: 8856369
• Product Code: JWH
• UDI-Device Identifier: 00885556655887
• UDI-Public: 00885556655887
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K170648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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: 71422945
• Device Lot Number: 21EM08962
• 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: 07/22/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2021
• 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: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 53 KG