MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CPCS TRL NK SZ 1H-2H; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 71362704

Device Problem Component Missing (2306)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/03/2018

Event Type  malfunction  

Event Description

It was reported that the magnetic part of the trial neck of the cpcs is missing.There was an operation and it doesn't know if this piece could be inside of the patient.They are x raying the patient to find out this.

Manufacturer Narrative

The associated cpcs trial neck was not returned for evaluation.It was reported that the tracking number for this complaint contained other devices.This complaint device was not received with this tracking number.After repeated requests, smith and nephew has been unable to obtain whether the device was shipped in the package.Thus, visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined since the product was not returned.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.If the product associated with this event is returned at a future date, the evaluation will be reopened for investigation.There are several potential factors that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended to inspect the device prior to/after each use and cleaning.A review of manufacturing records could not be performed, as the relevant lot/batch number was not provided.However, there is no indications to suggest the device did not meet product specifications upon release into distribution.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: CPCS TRL NK SZ 1H-2H
• 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: 8034062
• MDR Text Key: 125984338
• Report Number: 1020279-2018-02359
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010467072
• UDI-Public: 03596010467072
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

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: Health Professional
• Device Catalogue Number: 71362704
• Initial Date Manufacturer Received: 10/03/2018
• Initial Date FDA Received: 11/02/2018
• Supplement Dates Manufacturer Received: 10/03/2018
• Supplement Dates FDA Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1