MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TITANIUM MODULAR HEAD SLEEVE +0MM SHORT; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71344247
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/15/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient experienced increased nickel levels in 2014 as 2.39.In (b)(6) 2018, it was reported a decreased nickel level but were still above upper limit with value of 1.2.
Additional Manufacturer Narrative
The associated anthology porous stem, r3 acetabular shell and titanium modular head sleeve were not returned for evaluation.However, device details were provided.Thus, a review of device history record and complaint history were performed.The review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of complaint history on the listed parts revealed no prior complaints for the listed batch with the same failure mode.This investigation could not determine a specific cause of failure.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Our clinical evaluation noted that there are no lab results confirming the increased nickel levels and no supporting medical documentation have been provided to conduct a thorough clinical investigation.Additionally, there are no reports of how the increased nickel levels were treated or the patient's current condition.Due to the limited information, a clinical assessment is not able to be performed.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: TITANIUM MODULAR HEAD SLEEVE +0MM SHORT
• 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: 8105841
• Report Number: 1020279-2018-02598
• Device Sequence Number: 1827612
• Product Code: MBL
• UDI-Device Identifier: 00885556022757
• UDI-Public: 00885556022757
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K093363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: foreign,study,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2019

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 Expiration Date: 12/27/2021
• Device Catalogue Number: 71344247
• Device Lot Number: 11LT12415
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 05/07/2019
• 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: Other
• Patient Age: 60 YR