MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE LNR 40MM ID X 56OD; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number 71338687

Device Problems Degraded (1153); Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Joint Dislocation (2374)

Event Date 06/09/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that after a total hip replacement procedure performed on 2016; the patient experienced a fall that led to several dislocations and a subsequent damage to the liner.This adverse event was treated with a revision surgery on (b)(6) 2022.The patient is currently well and recovering.

Manufacturer Narrative

The device was not returned for evaluation, the reported event of dislocation could not be confirmed but the damage of the liner could be confirmed with the intraoperative photo.The clinical/medical investigation concluded that, per case details, approximately six years post total hip replacement surgery, it was reported the patient experienced a ¿mechanical fall¿ which led to several dislocations and a subsequent revision due to a damage liner.One intraoperative photo of the of the liner was reviewed and appears to show evidence of damage.The patient¿s current health status is reportedly ¿well and recovering.¿ no additional requested supporting documentation was provided.Without the requested clinically relevant supporting documentation or the return of the implants, a thorough medical investigation cannot be rendered not can the root cause of the reported failure be determined.However, we cannot rule out the reported fall as a likely contributing factor.The patient is reportedly, ¿well and recovering.¿ a review of the manufacturing records 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 hip systems revealed that dislocation has been identified as warnings and precautions.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.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.The contribution of the device to the reported event could be corroborated since it was damaged and a revision surgery was required.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.We consider this investigation closed.

• Brand Name: R3 20 DEG XLPE LNR 40MM ID X 56OD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, 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: 14861223
• MDR Text Key: 295048671
• Report Number: 1020279-2022-03181
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 00885556113189
• UDI-Public: 00885556113189
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71338687
• Device Catalogue Number: 71338687
• Device Lot Number: 14MM18551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2014
• 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
• Patient Age: 76 YR
• Patient Sex: Male