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 Mechanical Problem (1384)

Patient Problem Injury (2348)

Event Date 04/23/2018

Event Type  Injury  

Event Description

It was reported that a delay greater than 1 hour occured during a thr due to connection problem between the implants.A backup device was finally used to complete the surgery.

Manufacturer Narrative

The associated complaint device was returned and evaluated.A lab analysis indicated that some scratches on the face of the shell.No other marks found.The od porous surface was examined visually and there were no scratches or marks.Upon visual inspection of the liner, some scratches and deformation were exhibited around edges of the equator's face and within the geometry of locking splines.No other damage noted.Dimensional inspection of the shell indicated that all dimensions were within specifications limit.The liner also did not reveal any out of specifications except where noted damage had occurred.The damage could be the result of failed impaction as stated in the complaint.There is no evidence of deviations for material or manufacturing processes.No conclusions for this issue could be made.The shell was found to meet the print specification.A potential failure mode could not be determined.The liner was found to be too damaged to be inspected accurately.A potential failure mode could not be determined.A clinical analysis indicated that this complaint reports an intra-operative implant to implant connection malfunction during a thr resulting in a two hour delay in the procedure.Based on the product analysis the root cause of the connection problem could not be determined.However, a user/procedural variance cannot be ruled out as a contributing factor.It was further reported that neither the delay in the procedure nor a functional issue in the implant resulted in any harm or adverse patient outcome.Since the procedure was completed, and no further harm is being alleged beyond the two hour delay and the added risk associated, no further clinical/medical assessment is warranted at this time.Based on this investigation, the need for corrective action is not indicated.Should 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: 7506438
• MDR Text Key: 107982423
• Report Number: 1020279-2018-00908
• 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: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71336452
• Device Lot Number: 17CM00150
• Date Manufacturer Received: 04/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other