MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Model Number 71335556

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

Patient Problem Joint Dislocation (2374)

Event Date 02/04/2022

Event Type  Injury  

Event Description

It was reported that, after thr surgery had been performed on (b)(6) 2022 the patient experienced dislocation due to the components being placed in a sub-optimal position.This adverse event was solved by revision surgery to explant the complete system on (b)(6) 2022.The physician revised an r3 3 hole acet shell 56mm.The current health status of the patient is unknown.

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Event Description

It was reported that, after thr surgery had been performed on (b)(6) 2022 the patient experienced dislocation due to the components being placed in a sub-optimal position.This adverse event was solved by revision surgery to explant the complete system on (b)(6) 2022.The physician revised an r3 3 hole acet shell 56mm.The current health status of the patient is unknown.

Manufacturer Narrative

The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, he patient had a thr with the r3 system and two days later had a revision due to dislocation.It was noted via the attachments that no further clinical documentation is available.Therefore based on insufficient information, a thorough medical investigation cannot be performed.However, we are unable to rule out a procedural variance as a contributing factor to the reported dislocation as it was noted that the components were placed in a suboptimal position.The surgical technique states that the final position of the acetabular component should be approximately 45 degrees of abduction and 20 degrees of anteversion or at the surgeon¿s desired acetabular cup orientation.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.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 risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the instructions for use for this device reveal in the warnings and precautions, intraoperative section, that proper positioning of the components is important to minimize impingement which could lead to early failure, premature wear, device related noise, and/or dislocation, all of which may lead to revision surgery.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 not be corroborated.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 3 HOLE ACET SHELL 56MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• 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: 13591625
• MDR Text Key: 286062374
• Report Number: 1020279-2022-00851
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 03596010598264
• UDI-Public: 03596010598264
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070756
• 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: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71335556
• Device Catalogue Number: 71335556
• Device Lot Number: 18CW00017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2022
• Date Device Manufactured: 03/19/2018
• 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; Required Intervention