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

Catalog Number	71357003
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to stiffening.Cup, poly, stem and head were removed.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to stiffening.The associated oxinium femoral head, r3 acetabular liner and anthology porous femoral component standard offset were not returned for evaluation.Thus a product evaluation could not be performed.However, device details were provided.The manufacturing records and complaint history review was conducted.The review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.The 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.The clinical evaluation noted the provided x-rays do not indicate a reason for the reported stiffness.Based on the information provided the reported pain and stiffening was due to the stem being loose.It was communicated that the stem had no bony ingrowth, which surgeon thought that polar stem might have been an option due to patients bone quality.The future impact to the patient beyond the revision cannot be determined.Without the return of the actual products involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or 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: 8547328
• Report Number: 1020279-2019-01670
• Device Sequence Number: 1744666
• Product Code: JDI
• UDI-Device Identifier: 03596010559463
• UDI-Public: 03596010559463
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K052792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/22/2019

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: 71357003
• Device Lot Number: 16LM06002A
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 10/22/2019
• 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