MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT SLVLS MONO STEM 300MM SZ 16 {} HO; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number 71354758

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Hip Fracture (2349); Deformity/ Disfigurement (2360); Limb Fracture (4518)

Event Date 07/20/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that after a right tka initial surgery performed about two years ago, the patient fall resulting in a fractured femur which lead to redapt slvls mono stem 300mm sz 16 {} ho subsidence of the redapt stem that was already in-situ.Both the redapt slvls mono stem 300mm sz 16 {} ho and the biolox option ce ball head 12/14 36s were explanted.New redapt stem and head placed without issue.Further information is unknown and unavailable.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation but according to the clinical/medical investigation the three photos and x-ray were reviewed, and the pre-operative x-ray shows the plate and cables as well as confirms the reported femoral fracture.The femoral fracture, subsidence, and subsequent revision were reported to have been a result of the patient¿s fall.It cannot be concluded that the reported events were a result of a malperformance of the implant.The patient impact beyond the revision cannot be determined.However, it was noted, ¿the new redapt stem and head placed without issue.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for hip systems revealed that implant migration or subsidence has been identified as an intraoperative warning and precaution.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 reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or potential causes that could contribute to the reported event include patient bone quality and/or traumatic injury.The contribution of the device to the reported event could not be corroborated.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: REDAPT SLVLS MONO STEM 300MM SZ 16 {} HO
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• 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: 15136793
• MDR Text Key: 296950469
• Report Number: 1020279-2022-03574
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00885556579770
• UDI-Public: 00885556579770
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K151902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

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?: No
• Device Model Number: 71354758
• Device Catalogue Number: 71354758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2022
• Initial Date FDA Received: 07/30/2022
• Supplement Dates Manufacturer Received: 09/07/2022
• Supplement Dates FDA Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 75007735/BIOLOX OPTION CE BALL HEAD 12/14 36S
• Patient Age: 80 YR
• Patient Sex: Female