MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY HO POR PL HA SZ 8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC, CEMENTED OR UNCEMENTED

Catalog Number	71357108
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a loose stem.Stem and femoral head were removed.
Additional Manufacturer Narrative
The associated devices were returned and evaluated.A visual inspection of retrieved oxinium head revealed scaring near bottom edge of articular surface.This is most likely due to contact with metal instruments used during removal.Additional scaring and more minor scratches observed within the articular surface of the head and scaring on the anterior/posterior sides of the neck.Also noted some porous coating was missing along the medial edge of the proximal coated area.The scratches and missing porous coating were most likely due to contact with instruments during stem removal.No visual evidence of ha coating residual or of any bone on growth noted.There is no indication of material or process deviations for these components.Inspection of the retrieved components did not provide information from which a cause for the reported issue could be determined.A dimensional evaluation was conducted on both devices and both devices fail into the print specifications.A review of complaint history on the listed parts revealed no prior complaint for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A clinical evaluation was conducted and no supporting clinical/medical documents have been provided.Therefore a thorough investigation cannot be performed.The components were returned, however they do not reveal what the "pedestal in the canal" was.Should any relevant clinical/medical information become available this complaint can be re-assessed.Based on this investigation, the need for corrective action is not indicated.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: ANTHOLOGY HO POR PL HA SZ 8
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7397064
• Report Number: 1020279-2018-00717
• Device Sequence Number: 785186
• Product Code: MRA
• UDI-Device Identifier: 03596010559630
• UDI-Public: 03596010559630
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2018

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: 02/26/2026
• Device Catalogue Number: 71357108
• Device Lot Number: 16BM20685
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 07/03/2018
• 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: Required Intervention