MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF INTERFIT THRD HOLE COVER; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number 71330001

Device Problem Defective Device (2588)

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

Event Date 07/15/2021

Event Type  Injury  

Event Description

It was reported that, during a thr surgery, after implanting the r3 cup, the central screw-plug was implanted.The screw appears to be properly adjusted and implanted.When inserting an unknown xlpe liner it is impossible to impact it on the cup.The physician decides to remove the interfit threaded hole cover and inserts the plastic without the central screw-cap.The xlpe liner this time is correctly implanted.Surgery was completed after a non significant delay, patient was not harmed as consequence of this problem.

Manufacturer Narrative

Results of investigation: the device was returned and evaluated.The contribution of the device to the reported event could not be corroborated.A visual inspection of the returned device did not confirm the stated failure mode.Additional product evaluation could not confirm the failure mode.The device was found to be within specifications.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.The anticipated risk level is sill adequate.A potential probable cause could be but is not limited to poor insertion technique.Based on this investigation, the need for corrective action is not indicated.Assessment of historical escalated cases concluded that there are prior actions related to this product and failure mode, but not related to this specific batch.This is considered an isolated event, however, we will continue to monitor this failure mode in the future.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: REF INTERFIT THRD HOLE COVER
• 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: 12277458
• MDR Text Key: 265062436
• Report Number: 1020279-2021-06165
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010196590
• UDI-Public: 03596010196590
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 71330001
• Device Catalogue Number: 71330001
• Device Lot Number: 21EM03148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/04/2021
• Supplement Dates Manufacturer Received: 12/28/2021
• Supplement Dates FDA Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2021
• 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
• Patient Outcome(s): Required Intervention