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

Model Number	71330001
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during hip replacement, two (2) reflection interfit threaded hole covers failed to be screwed into the implanted r-3 acetabular cup 52-mm.Surgery was resumed, after a non-significant delay, with a change in surgical technique.This change was made in a way in which the cup hole was left unscrewed and a r-3 xlpe r3 xlpe acetabular liner 52/36-mm was inserted directly.Patient was not harmed as consequence of this problem.
Additional 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.A quality engineer evaluated the two returned devices for all features related to thread engagement with the associated acetabular shell device.One device passed all associated inspections.The other device was determined to be out-of-tolerance and oversized for the major diameter of the thread.This deviation could potentially contribute to the observed failure mode.The clinical/medical evaluation concluded that, based on the product evaluation, although one device passed all associated inspections, one hole-cover was oversized and ¿could potentially contribute to the observed failure mode¿.It is possible that the out of tolerance hole-cover was used during the first attempt and could have contributed to difficult/unsuccessful insertion of the second cover attempted; however, this could not be definitively concluded.The associated surgical techniques state or imply to use hole covers if desired; therefore, patient impact would not be likely.Reportedly, there was an insignificant 0-30 minute surgical delay, the ¿patient was not harmed as consequence of this problem¿, and the surgeon was satisfied with the surgical outcome without use of the hole cover/change in surgical technique.Further patient impact would not be anticipated based on the information provided.No further medical assessment could 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 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.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.We consider this investigation closed.D10: add concomitants.

• Brand Name: REF INTERFIT THRD HOLE COVER
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12129374
• Report Number: 1020279-2021-05776
• Device Sequence Number: 19739067
• Product Code: MBL
• UDI-Device Identifier: 03596010196590
• UDI-Public: 03596010196590
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K960094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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
• Operator of Device: Health Professional
• Device Model Number: 71330001
• Device Catalogue Number: 71330001
• Device Lot Number: 21DM18086
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: R3 0 DEG XLPE ACET LNR 36MM X 52MM/21DM04989; R3 0 HOLE ACET SHELL 52MM/20LW16694
• Outcome Attributed to Adverse Event: Required Intervention