MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN ORTHOPAEDIC RECONSTRUCTION DEV; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number UNKNOWN

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Inadequate Osseointegration (2646)

Event Date 12/30/2023

Event Type  Injury  

Event Description

It was reported that, after a thr was performed on (b)(6) 2023, a revision surgery was performed on (b)(6) 2023 due to implant loosening in the cement interface.The s+n cement cup was converted to a pinnacle constrained competitor implant.It is unknown the patient current health status.Further information is unknown.

Manufacturer Narrative

H10: internal complaint reference: case (b)(4).

Manufacturer Narrative

H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, it was reported that, after a total hip replacement was performed on (b)(6) 2023, a revision surgery was performed on (b)(6) 2023 due to implant loosening in the cement interface.The smith and nephew cement cup was converted to a pinnacle constrained competitor implant.As this case was received from medwatch additional medical documentation is not available; therefore a clinical root cause for the reported event cannot be determined.The patient impact was the reported revision and expected post operative convalescence period.No further clinical assessment is warranted at this time.Device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, risk management file and prior actions could not be performed.A review of the instructions for use documents for total hip systems revealed that failure to observe the warnings and precautions, trauma, strenuous activity, implant alignment, patient non-compliance, involuntary muscular disorders, improper or duration of service increase the risk of loosening, bending, cracking, or fracture of implant components, which may lead to revision surgery.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, inadequate integration between the cement and bone/implant, and/or traumatic injury.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: UNKN ORTHOPAEDIC RECONSTRUCTION DEV
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, 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: 18707934
• MDR Text Key: 335406702
• Report Number: 1020279-2024-00375
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2024
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 03/18/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization