MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT SLVD MONO STEM 240MM SZ 22 HO; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 71354829

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

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case-2024-00205223-1.This complaint was opened by smith+nephew to document a patient complication identified through the review of clinical evidence from post market clinical data collection activities that includes reference to the use of a smith+nephew product.The reported issue(s) relate 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.

Event Description

It was reported that, during a right tha conversion performed on an unknown date due to failed right hip arthroplasty with history of infection, severe bone loss and abductor deficiency, the patient sustained an intraoperative femoral fracture at the tip of the stem.No further information is available.

Manufacturer Narrative

H3, h6: although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the redapt stem.Given the nature of the alleged incident, the device could not be returned for evaluation; therefore, a device analysis could not be performed.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 the warnings and precautions section that congenital deformity, improper implant selection, improper broaching or reaming, osteoporosis, bone defects due to misdirected reaming, trauma, strenuous activity, improper implant alignment or placement, patient non compliance, etc.Can increase risk of femoral or pelvic fractures.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 patient bone quality and/or surgical technique.Based on this investigation, the need for corrective action is not indicated.Should 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 SLVD MONO STEM 240MM SZ 22 HO
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: 19149506
• MDR Text Key: 340676777
• Report Number: 1020279-2024-00793
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00885556580165
• UDI-Public: 00885556580165
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 71354829
• Device Lot Number: 16KTM0063E
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Date Device Manufactured: 01/05/2017
• 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
• Treatment: PN: 71342800 / LN: 18GM01046; PN: 71354223 / LN: 13FM08183A; PN: 71354238 / LN: 17FM15724; PN: 75018960 / LN: B1510783
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Sex: Male