MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF LNR 28X 62-64 20DG SZ H; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71742862
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to poly wear & stem loosening.X-rays and notes not available.Surgeon does not blame device.
Additional Manufacturer Narrative
The associated reflection liner was not returned for evaluation.Therefore visual inspection could not be performed.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.After repeated requests, smith and nephew has been unable to obtain device details.Thus, a review of the manufacturing records could not be performed.Complaint history review could not be performed with any accuracy due to lack of batch information.There is no information that would suggest the implanted device failed to meet specifications.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.A clinical analysis noted that no clinical documents were provided.Therefore, no thorough clinical assessment of the reported issue can be rendered at this time.Without the return of the actual product involved and no batch information available, our investigation of this report is inconclusive.If the product associated with this event is returned at a future date, the evaluation will be reopened for investigation.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, this complaint will be reopened and reevaluated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: REF LNR 28X 62-64 20DG SZ H
• 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: 8051807
• Report Number: 1020279-2018-02391
• Device Sequence Number: 1484616
• Product Code: JDI
• UDI-Device Identifier: 03596010455703
• UDI-Public: 03596010455703
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K002747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2019

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 Expiration Date: 01/27/2025
• Device Catalogue Number: 71742862
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 10/17/2018; 10/17/2018
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 04/24/2019; 05/04/2019
• 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
• Patient Age: 72 YR