MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY SO POR PL HA SZ 8; PROSTHSISHIPSMICONSTRAINDMTALCRAMICCRAMICMTALCMNTDORUNCMNTD

Model Number 71357008

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

Patient Problems Failure of Implant (1924); Unequal Limb Length (4534)

Event Date 04/18/2022

Event Type  Injury  

Event Description

It was reported that, after a thr surgery had been performed on (b)(6) 2022, the patient had a leg length discrepancy.The adverse event was addressed with a revision surgery on (b)(6) 2022 to replace the anthology so por pl ha sz 8 and the oxinium fem hd 12/14 32mm +0.The condition of the patient is unknown.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this case reports, a revision was performed 4 days post primary thr due to patient¿s leg length discrepancy.The patient¿s current health status was not provided.Smith and nephew has not received the requested patient specific documentation, the explanted device, and/or adequate materials to fully evaluate the root cause of the complaint.Patient impact beyond that which was reported (leg length discrepancy and subsequent revision) could not be determined.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.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 total hip systems revealed in warnings and precautions that an appropriate type and size should be selected for patients with consideration of anatomical and biomechanical factors.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 surgical technique used, patient anatomy, size of device or user/procedural variance.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: ANTHOLOGY SO POR PL HA SZ 8
• Type of Device: PROSTHSISHIPSMICONSTRAINDMTALCRAMICCRAMICMTALCMNTDORUNCMNTD
• 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: 14375912
• MDR Text Key: 291510100
• Report Number: 1020279-2022-02338
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 03596010559517
• UDI-Public: 03596010559517
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

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 Operator: Health Professional
• Device Model Number: 71357008
• Device Catalogue Number: 71357008
• Device Lot Number: 21EM07875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 05/12/2022
• Supplement Dates Manufacturer Received: 06/03/2022
• Supplement Dates FDA Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization