MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71336452

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Information (3190)

Event Date 10/31/2018

Event Type  malfunction  

Event Description

During right total hip replacement surgery, the screw goes through the acetabular outer cup.

Manufacturer Narrative

The associated reflection 3 hole shell was not returned for evaluation.Our investigation including a review of the manufacturing records for the listed part with the listed batch did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.Our clinical evaluation noted that the x-ray provided confirms the screw through the shell but details on placement or details of the screw were not included.Without additional information we can¿t comment on the stability of the cup or the placement of the screw through the cup as it does have 2 others.In addition, ¿the implantation of the screw under power¿, as a likely contributing factor cannot be ruled out.Since a revision has not been planned, the future impact to the patient beyond the possibility of screw migration cannot be determined.Should additionally clinical information be provided this complaint will be re-assessed.Our investigation indicated this issue has been communicated to the product support group for consideration for further action.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: REF THREE HOLE SHELL 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8100345
• MDR Text Key: 128253743
• Report Number: 1020279-2018-02571
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010454355
• UDI-Public: 03596010454355
• 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: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71336452
• Device Lot Number: 17JM18572
• Date Manufacturer Received: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR