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

Catalog Number	71344248
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Limited Mobility Of The Implanted Joint (2671)
Date of Event	01/30/2018
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7279382
• Report Number: 1020279-2018-00188
• Device Sequence Number: 957689
• Product Code: MBL
• UDI-Device Identifier: 00885556022962
• UDI-Public: 00885556022962
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K093363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 04/13/2026
• Device Catalogue Number: 71344248
• Device Lot Number: 16DT67802
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2018
• Supplement Date Received by Manufacturer: 02/07/2018; 02/07/2018
• Initial Report FDA Received Date: 02/17/2018
• Supplement Report FDA Received Date: 02/22/2018; 04/17/2018
• 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: Other; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 66