MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY SO POR PL HA SZ 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71357003
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Swelling (2091)
Date of Event	10/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to swelling and pain.Liner, head and stem were removed.
Additional Manufacturer Narrative
It was reported, that a revision surgery was performed, due to swelling and pain.Liner, head and stem were removed.The associated head and liner, used in treatment, were returned and the stem is not returned.A lab analysis conducted during this investigation noted, that the inspection of the head did not reveal any unusual or unexpected markings.The polyethylene liner did not show any abnormal wear or markings.There is nothing visually to indicate these components contributed to the issues requiring revision surgery.A review of manufacturing records 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.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.This reported failure has been identified in the instructions for use and risk management files.No relevant supporting documentation was provided.Therefore, a thorough medical investigation could not be performed.Some potential causes of the reported event could include, but are not limited to traumatic injury, joint tightness or patient reaction.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 SO POR PL HA SZ 3
• 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: 9281455
• Report Number: 1020279-2019-03895
• Device Sequence Number: 10865386
• Product Code: JDI
• UDI-Device Identifier: 03596010559463
• UDI-Public: 03596010559463
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K052792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2020

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 Model Number: 71357003
• Device Catalogue Number: 71357003
• Device Lot Number: 17DM2171
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 07/15/2020
• 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