MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPEC EF PRI SO 12/14 SZ 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71312101
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient presented with loosening of left hip.Revision surgery was performed and replaced the stem along with 28mm oxinium head and all cemented cup.
Additional Manufacturer Narrative
The associated spectron ef standard offset stem was not returned for evaluation.Our investigation included a review of the manufacturing records for the listed batch which did not reveal any deviation from the standard manufacturing processes.A review of complaint history on the listed part revealed no additional complaints for this failure mode with the same batch number.A clinical evaluation performed in this investigation noted that all documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.Based on the information available, the root cause of the polyethylene wear and osteolysis which reportedly lead to the loosening cannot be concluded from the x ray picture and the pictures of the components.As stated no patient information was forthcoming and the products were not returned.Should any relevant clinical/medical information become available the 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.We consider this investigation closed.

• Brand Name: SPEC EF PRI SO 12/14 SZ 1
• 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: 7148139
• Report Number: 1020279-2017-01346
• Device Sequence Number: 13762723
• Product Code: JDI
• UDI-Device Identifier: 03596010195517
• UDI-Public: 03596010195517
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K970351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2018

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: 04/28/2015
• Device Catalogue Number: 71312101
• Device Lot Number: 05DT88941
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 05/10/2018
• 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: Hospitalization; Required Intervention