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

Catalog Number	71362704
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• 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: 8034062
• Report Number: 1020279-2018-02359
• Device Sequence Number: 1262527
• Product Code: JDI
• UDI-Device Identifier: 03596010467072
• UDI-Public: 03596010467072
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 71362704
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1