MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT SLVLS MONO STEM 300MM SZ 17 SO; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number 71342200

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

Patient Problems Bone Fracture(s) (1870); Hip Fracture (2349)

Event Date 09/27/2021

Event Type  Injury  

Event Description

On the pmcf titled dca-1000 accord ss clinical dataset, it was reported that, after undergoing right tha, one (1) patient experienced a right periprosthetic femur fracture.This adverse event was treated by performing a revision surgery combined with internal fixation on (b)(6) 2021, in which an accord cable system was implanted.A post-operative follow-up determined that the patient presents consolidation of periprosthetic fracture with no migration of trochanter.

Manufacturer Narrative

Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from a post-market clinical follow-up activity 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.

Manufacturer Narrative

Initial complaint was created against oxinium fem hd 12/14 22 mm +0; a case re-assessment determined that, since a femur fracture occurred, complaint must be against the femoral stem.71342200 added as concomitant.Corrected data: d1/d2a/d2b: brand name, product code.D4: catalog number, lot number, expiration date, udi.D10: concomitant medical products.G3 / g4: pma/510(k)number.H4: device manufacture date.

Manufacturer Narrative

H3, h6: given the nature of the alleged incident, the devices, could not be returned for evaluation.The clinical/medical investigation concluded that, as of the date of this medical investigation, patient-specific supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The patient impact beyond the reported events cannot be determined with the information provided.No further clinical assessment is warranted at this time.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed devices.A review of instructions for use for total hip systems and or3o¿ dual mobility system revealed in precautions 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 files 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 these products and event.At this time, we have no reason to suspect that the products 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.Corrected data: h6 (health effect - clinical code).

• Brand Name: REDAPT SLVLS MONO STEM 300MM SZ 17 SO
• 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: 16583106
• MDR Text Key: 311680114
• Report Number: 1020279-2023-00600
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00885556579626
• UDI-Public: 00885556579626
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2023

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 Model Number: 71342200
• Device Catalogue Number: 71354742
• Device Lot Number: 16JTM0052G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 03/16/2023; 05/26/2023
• Supplement Dates FDA Received: 04/14/2023; 06/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/16/2021
• 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: INSRT ACT OR3O 40X22MM(PN:71358216,LN:A2016481).; INSRT ACT OR3O 40X22MM(PN:71358216,LN:A2016481).; LNR ACET OR3O 52X40MM(PN:71358203, LN:20MM00179).; LNR ACET OR3O 52X40MM(PN:71358203, LN:20MM00179).; OX FM HD 12/14 22MM+0(PN:71342200,LN:21HM11681).; OX FM HD 12/14 22MM+0(PN:71342200,LN:21HM11681).; STM RDPT TI12/14 42MMTP(PN:71354742,LN:16JTM0052G).
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female