MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TANDEM BIPOLAR/UNIPOLAR IMPL; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL

Catalog Number UNKNOWN

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 11/19/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Postal code (b)(6).

Event Description

It was reported that after an unknown procedure, a revision surgery was performed on (b)(6) 2021 due to pain and migration.The surgeon stated that the devices were not defective.No patient harm beyond the described event.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that smith and nephew has not received the device/adequate clinical documentation to fully evaluate the complaint.Therefore, the impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Per the surgeon, ¿the smith and nephew devices were not defective.¿ should any additional relevant patient information be provided, this complaint would be re-assessed.No further clinical/medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction, loss of sterility, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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.

• Brand Name: UNKN TANDEM BIPOLAR/UNIPOLAR IMPL
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL
• 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: 12974636
• MDR Text Key: 282032300
• Report Number: 1020279-2021-08601
• Device Sequence Number: 1
• Product Code: LZY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Other