MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TITANIUM MODULAR HEAD SLEEVE +4MM MEDIUM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71344248

Device Problem Insufficient Information (3190)

Patient Problem Limited Mobility Of The Implanted Joint (2671)

Event Date 01/30/2018

Event Type  Injury  

Event Description

It was reported that a surgical intervention was performed due to a subsided stem.The stem, the oxiniun modular head and the titanium modular head were removed.

Manufacturer Narrative

The affected titanium modular head sleeve was not returned for evaluation.A review of the manufacturing or product specifications for the listed batch did not reveal abnormalities that could have contributed to the reported issue.The device was manufactured in 2016.A review of complaint history for listed part revealed no prior complaints for this failure mode with the same batch number.Our clinical evaluation noted that based on the lack of clinical/medical information, the root cause of this patients ¿loosening/subsidence¿ cannot be concluded.The cause may have been as the physician suggested the cancer and chemo therapy.Should any relevant information become available this complaint can be re-assessed.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: TITANIUM MODULAR HEAD SLEEVE +4MM MEDIUM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7279382
• MDR Text Key: 100388148
• Report Number: 1020279-2018-00188
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 00885556022962
• UDI-Public: 00885556022962
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2018

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: 71344248
• Device Lot Number: 16DT67802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2018
• Initial Date FDA Received: 02/17/2018
• Supplement Dates Manufacturer Received: 02/07/2018; 02/07/2018
• Supplement Dates FDA Received: 02/22/2018; 04/17/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 66