MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF LNR 28ID 20 DEG SZ F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71742854
Medical Device Problem Code	Naturally Worn (2988)
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
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 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.The available information in the clinical/medical evaluation states that the root cause of the revision was extensive poly age related wear, therefore, a device history records review for this incident is considered unnecessary.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: REF LNR 28ID 20 DEG SZ F
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 1450 brooks road; memphis, TN 38116 ; 5123913905
• MDR Report Key: 11587198
• Report Number: 1020279-2021-02482
• Device Sequence Number: 4182325
• Product Code: LPH
• UDI-Device Identifier: 03596010232274
• UDI-Public: 3596010232274
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K932755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2021

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: 71742854
• Device Lot Number: 00313813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Unknown