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

Model Number 71330001

Device Problems Positioning Failure (1158); Incomplete or Inadequate Connection (4037)

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

Event Date 07/06/2021

Event Type  malfunction  

Event Description

It was reported that, during a thr surgery, the central screw in the ref interfit thrd hole cover tilted in such way when closing the central hole that the insertion of the inlay was not possible and the already implanted r3 0 hole acet shell 52mm had to be removed.The surgeon tried intraoperatively to remove the jammed hole-cover screw with the rigid screwdriver r3 and a hex wrench.However, the last attempt with the hex wrench failed completely, because it broke off and a part of the hex wrench is still stuck in the thread of the screw and cup.Surgery was successfully completed by implanting an identical replacement cup implant with replacement central screw, after a non-significant delay.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.The device shows signs of extensive use.Dimensional analysis could not be completed on the returned device.Attempted removal of the hole cover device from the associated acetabular shell with an unapproved tool by the customer resulted in the tool breaking off into the device.It it is not possible to disconnect the device without potentially damaging both the hole cover and acetabular shell.The failure mode cannot be confirmed via dimensional analysis.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.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.Based on this investigation, the need for corrective action is not indicated.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.

Manufacturer Narrative

Section h10: the associated device was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.The device shows signs of extensive use.The dimensional analysis could not be completed on the returned device.Attempted removal of the hole cover device from the associated acetabular shell with an unapproved tool by the customer resulted in the tool breaking off into the device.It it is not possible to disconnect the device without potentially damaging both the hole cover and acetabular shell.The failure mode cannot be confirmed.The clinical medical evaluation concluded that based on the limited information provided we are currently unable to rule out a procedural/ user variance as a contributing factor to the reported event, which does not represent a device malfunction.Per case details, an off label device was used along with the smith and nephew products, and broke within the r3 cup.Two post procedural x-rays were provided for review however, they do not contribute to the root cause of the reported events.Provided photos confirm the reported breakage.The failure mode cannot be confirmed via dimensional or visual analysis.It was noted that the procedure was completed using a back-up device.The patient status was reported as fine.Since no patient injuries are being reported, no further clinical assessment is warranted.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 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 revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.The contribution of the device to the reported event could not be corroborated.For the correct implantation of this device, the threads have to be aligned correctly with the corresponding receptor threads.Failure to align these parts could result in material deformation, causing the device to jam and become inoperative.Some potential probable causes for this event could include a fit/sizing issue, misalignment at the time of insertion, device cross-thread or poor insertion technique.Based on this investigation, the need for corrective action is not indicated.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.Internal complaint reference number: case-2021-00062987-1 (note: this event is associated with the report number 1020279-2021-06027 (our reference number: case-2021-00062987-2)).Section h1 and h6 were corrected.

• 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: 12171140
• MDR Text Key: 261703007
• Report Number: 1020279-2021-05980
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010196590
• UDI-Public: 03596010196590
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K960094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71330001
• Device Catalogue Number: 71330001
• Device Lot Number: 21DM05936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2021
• 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