MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY HO TR NECK SZ 1-6; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71365801
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the procedure, thr, that the coating on trial necks wear off, causing that the magnet detaches from the trial neck.The procedure was completed without delay, using the same device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.A visual inspection of the returned device confirmed the stated failure mode.The coating on the magnet is no longer visible rendering the device inoperable.The device was manufactured in 2020 and shows signs of extensive use.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Should additional information be received, the complaint will be reopened.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.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.

• Brand Name: ANTHOLOGY HO TR NECK SZ 1-6
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10667943
• Report Number: 1020279-2020-05343
• Device Sequence Number: 2605840
• Product Code: JDG
• UDI-Device Identifier: 03596010559876
• UDI-Public: 03596010559876
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71365801
• Device Catalogue Number: 71365801
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1