MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE HA CTD ACET SHELL 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED

Model Number 71331948

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during a tka procedure, the r3 3 hole ha ctd acet shell 48mm had no grip.Surgery was resumed, with a less than or equal to 30 minutes delay, with a smith and nephew back-up device.The surgeon reamed up the acetabulum to the next cup size and implanted the definite cup.Patient was not harmed and had a great outcome in the end.

Manufacturer Narrative

Section 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, the acetabular shell 48mm had no grip during surgery.Per case communication, after the acetabulum was reamed, the definitive cup was implanted, and no trial was used.¿on impaction, the cup did not get the required fixation and ¿bone quality was softer than the surgeon anticipated.¿ per case correspondence, a backup device (smith and nephew) was opened.It was communicated that the surgeon again reamed up on the acetabulum to the next cup size and implanted the definitive cup.Reportedly, the procedure was completed with a less than or equal to 30 minutes delay and ¿patient was not harm and had a great outcome in the end.¿ 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 events 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 hip systems revealed that prior to use, inspect the device to ensure it is not damaged.Do not use a damaged device have been identified in 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 surgical technique or size of device.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 HA CTD ACET SHELL 48MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED
• 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: 14671933
• MDR Text Key: 293840845
• Report Number: 1020279-2022-02954
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010597724
• UDI-Public: 03596010597724
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71331948
• Device Catalogue Number: 71331948
• Device Lot Number: 20HM23093A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention