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

Catalog Number	71362631
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/07/2019
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9152682
• Report Number: 1020279-2019-03552
• Device Sequence Number: 19617292
• Product Code: JDI
• UDI-Device Identifier: 03596010462879
• UDI-Public: 03596010462879
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 09/07/2019
• Supplement Date Received by Manufacturer: 09/07/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR