MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ZIRC 12/14 FEM HD 28 + 4; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Catalog Number	71320428
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	03/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a (b)(6) years old thr, a revision surgery was performed due to extensive poly wear.Surgeon performed a standard posterior approach as per surgical technique also a debriment of the affected tissue.Metalosis was found.The zirc 12/14 fem hd 28 + 4 and ref lnr 28id 20 deg sz f were explanted and exchange for new poly and head.Patient outcome is unknown.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the failure mode was confirmed.The clinical/medical investigation concluded that, based on the documentation provided, the root cause of the revision after more than 20 years post implantation was extensive poly ¿age related wear¿ resulting in the eccentric positioning of the femoral head within the acetabular construct reportedly with intraop findings of metallosis.Poly wear after 20 years plus in-vivo would not be an unanticipated finding.Patient symptoms and date of onset was not provided; however, the x-ray and photo provided which appear to support the complaint suggests a lengthy degradation process.The patient impact beyond the reported findings and revision procedure could not be determined.No further medical assessment could be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Potential causes could include but are not limited to friction, joint tightness, lifetime of device, damaged product or implant corrosion based on this investigation, the need for corrective action is not indicated.Should the device or 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.

• Brand Name: ZIRC 12/14 FEM HD 28 + 4
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11587202
• Report Number: 1020279-2021-02483
• Device Sequence Number: 17189034
• Product Code: LZO
• UDI-Device Identifier: 03596010196255
• UDI-Public: 3596010196255
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K971414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

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: 71320428
• Device Lot Number: T04160001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 08/04/2021
• 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; Other; Required Intervention