MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CPCS STEM DRIVER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 71362631

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/07/2019

Event Type  malfunction  

Event Description

It was reported that during surgery the tip of inserter broke in the stem.Less than 30 minutes delay was reported and a backup device was available.One piece remained wedged inside the femoral component.

Manufacturer Narrative

The associated complaint device was returned for evaluation.A visual inspection of the returned stem inserter shows the tip is broken off.The complaint description states the tip is stuck in the stem.The stem was not returned for evaluation.The device was manufactured in 2002 and it shows signs of extreme wear usage.A clinical evaluation was conducted and based on the limited information provided, the root cause of the inserter tip breakage cannot be determined.The material, 17-4ph is not an implantable alloy; therefore, long-term implantation data is not available.Since the inserter tip was left wedged inside the femoral component, migration is unlikely.The impact to the patient is the retained non-implantable fragment of the externally communicating device, possible local irritation and/or discomfort, and additional radiological imaging/exposure cannot be completely ruled out.No further medical assessment can be rendered at this time.A review of the manufacturing records did not reveal any manufacturing abnormalities that could have caused or contributed to the reported incident.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: CPCS STEM DRIVER
• 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: 9152682
• MDR Text Key: 161092830
• Report Number: 1020279-2019-03552
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010462879
• UDI-Public: 03596010462879
• 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: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71362631
• Device Lot Number: 02BM08221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Initial Date Manufacturer Received: 09/07/2019
• Initial Date FDA Received: 10/03/2019
• Supplement Dates Manufacturer Received: 09/07/2019
• Supplement Dates FDA Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR