MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY HO POR PL HA SZ 5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71357105
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	12/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to the neck of the stem fractured.
Additional Manufacturer Narrative
The associated complaint device was not returned.Without the actual device involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, the complaint can be re-opened.The clinical medical investigation concluded that the x-rays provided confirm the report but cannot conclude a root cause of the broken neck.The lack of bone support or trauma cannot be ruled out.Based on the limited information provided and without the return of the device for evaluation, the root cause of the reported fractured neck stem cannot be determined.The impact to the patient beyond the revision cannot be concluded.Should additional information become available this issue can be re-elevated.No further clinical assessment is warranted at this time.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: ANTHOLOGY HO POR PL HA SZ 5
• 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: 8210164
• Report Number: 1020279-2019-00015
• Device Sequence Number: 1631081
• Product Code: JDI
• UDI-Device Identifier: 03596010559609
• UDI-Public: 03596010559609
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K052792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2019

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 Catalogue Number: 71357105
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 06/14/2019
• 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: Hospitalization; Required Intervention