MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF CUP POSITIONER/IMPACTOR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 71362299

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported a malfunction in which the device broke during impaction.While reviewing the historical data, it was found that another similar event caused a serious injury previously.

Manufacturer Narrative

The cup positioner impactors were returned and evaluated.A visual inspection confirmed the complaint that the strike platforms have fractured off from the body of the impactors.The strike plates were not returned and the fracture points have left sharp burs on both parts.This failure mode has been previously identified and a design change has been implemented to prevent the reoccurrence of the failure mode.The associated complaint devices were manufactured prior to the implementation of these changes.Damage to the threads was also observed and neither part could accept the appropriate mating part.The devices were manufactured in 2008 and exhibit heavy strike damage around the knurled handle.We recommend that all reusable instruments be routinely inspected for wear and damage so they can be replaced as necessary.The complaint history revealed no additional complaints for the associated batches.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: REF CUP POSITIONER/IMPACTOR
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7892064
• MDR Text Key: 120828437
• Report Number: 1020279-2018-01861
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010443236
• UDI-Public: 03596010443236
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/05/2018

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: Other
• Device Catalogue Number: 71362299
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Initial Date Manufacturer Received: 08/24/2018
• Initial Date FDA Received: 09/19/2018
• Supplement Dates Manufacturer Received: 08/24/2018
• Supplement Dates FDA Received: 11/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1