MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 HOLE ACET SHELL 56MM; PRSTHSS,HP,SEMI-CONSTRAINED,MTL/CRMC/CRMC/MTL,CEMENTED OR UNCEMENTED

Catalog Number	71331856
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had increased nickel, titanium and vanadium levels.No treatment has been given to patient.
Additional Manufacturer Narrative
The associated synergy porous plus standard offset stem, modular head sleeve and r3 0 hole acetabular shell were not returned for evaluation.The devices were manufactured in 2010 and 2011.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.Without the return of the actual product involved, our investigation of this report is inconclusive.A clinical evaluation noted that no clinical relevant documents were provided to conduct a thorough medical assessment.No medical assessment is warranted at this time.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: R3 0 HOLE ACET SHELL 56MM
• Common Device Name: PRSTHSS,HP,SEMI-CONSTRAINED,MTL/CRMC/CRMC/MTL,CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8123228
• Report Number: 1020279-2018-02647
• Device Sequence Number: 13526963
• Product Code: MRA
• UDI-Device Identifier: 03596010597618
• UDI-Public: 03596010597618
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: foreign,study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2019

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: 11/30/2021
• Device Catalogue Number: 71331856
• Device Lot Number: 11LM01084
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 12/02/2018
• Supplement Report FDA Received Date: 04/09/2019
• 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