MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 62MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLY, POROUS

Model Number 71336462

Device Problem Positioning Problem (3009)

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

Event Date 12/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the reflection xlpe liner did not lock in the shell.The procedure was completed using a s+n backup device.A surgical delay of 30 min or less was reported.No harm to the patient was reported.

Manufacturer Narrative

H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned device could not confirm the stated failure mode.The device shows signs of damage from attempted use.Dimensional evaluation was performed on the returned shell for all features critical to locking with the associated liner.A slight deviation was noted for internal spherical radius profile.However, there is visible surface damage within the inner radius of the shell that is potentially affecting the cmm profile scan in that area.It is unknown if the act of attempted implantation and/or explantation caused this internal damage.In either case, this minor deviation below lmc of the profile would not have resulted in the failure mode exhibited in this complaint.No other dimensional deviations were noted.The failure mode could not be confirmed via dimensional analysis of the returned device.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.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: REF THREE HOLE SHELL 62MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLY, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11111851
• MDR Text Key: 225034853
• Report Number: 1020279-2021-00049
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010454409
• UDI-Public: 03596010454409
• Combination Product (y/n): N
• PMA/PMN Number: K960094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71336462
• Device Catalogue Number: 71336462
• Device Lot Number: 14JM09131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Initial Date Manufacturer Received: 12/13/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 09/14/2021
• Supplement Dates FDA Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1