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

Catalog Number 71336452

Device Problem Positioning Problem (3009)

Patient Problem Injury (2348)

Event Date 10/17/2018

Event Type  Injury  

Event Description

It was reported that one month after surgery, in the review, it was found that one acetabular screw was completely through and out of the acetabular cavity.

Manufacturer Narrative

The associated reflection 3 hole shell was not returned for evaluation.Therefore, a product analysis could not be conducted.However, our investigation indicated that this failure has been previously identified.A quality hold was placed in an attempt to quarantine and re-inspect additional products for this failure mode.During the investigation, it was found that screw hole was damaged during the manual deburr operation.Consequently, corrective actions have been implemented to prevent recurrence of this failure mode.Our clinical evaluation noted that with the limited clinical details, no medical assessment can be rendered at this time.The patient impact beyond the potential screw migration, expected revision procedure/post-op rehab, possible additional radiological exposure and possible continued migration cannot be concluded.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation warranted for this complaint; however smith and nephew 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.

Event Description

It was reported that during the operation, the acetabular screw was through the acetabulum, two screws continuously with the same situation.One month after surgery, in the review, it was found that one acetabular screw was completely through and out of the acetabular cavity.It is considered that the hole dimension of the acetabular is the root cause for the failure of the hip system.

• Brand Name: REF THREE HOLE SHELL 52MM
• Type of Device: PROSTHESIS,HIP,SEMICONSTRAINED,UNCEMENTED,METAL/POLYMER,POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8064371
• MDR Text Key: 126931428
• Report Number: 1020279-2018-02443
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010197658
• UDI-Public: 03596010197658
• 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: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• 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: 17GM09503
• Date Manufacturer Received: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71306812/ 17HM10548; 71333334/ 15BMB0004A; 71336520/ 17HM09021; 76539161/ 17LT95036
• Patient Outcome(s): Other