MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY SO POROUS SIZE 6; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71356006

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Date 03/20/2017

Event Type  Injury  

Manufacturer Narrative

Additional information received, identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.

Event Description

It was reported that a revision surgery was performed due to a broken implant.

Manufacturer Narrative

The associated complaint device was not returned for evaluation.Please see the attached file for the results of our investigation.

Manufacturer Narrative

The associated complaint device was not returned.The medical investigation concluded that this complaint is being handled through smith and nephew's legal team; any responses to these queries are not immediately available to the members of smith and nephew's complaint/regulatory team and are not expected to be available for several months.This is due to the delivery timeframe of patient medical information and the device return being in the control of the patient's legal team, rather than smith and nephew.The smith and nephew legal team has confirmed that once any additional relevant complaint information is received, (i.E.Reason for complaint, part/lot numbers, patient medical records, surgeon, device availability, and dates of implantation/revision) it will be provided to the complaint/regulatory team, at which point the complaint will be reopened for investigation.Therefore, a clinical assessment could not be performed at this time.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.Visual inspection concluded of retrieved anthology femoral stem exhibited scratches and scarring on the anterior/posterior sides of the neck and indentations and deformation on the male taper; most likely caused during the removal process.The stem has no visual evidence of bone in-growth or on-growth in the porous coated area and has no sign of burnishing due to possible loosening of the stem in the grit blasted area; i.E.No signs of micro-motion visible.Our clinical team indicated that the root cause of the ¿failed tha¿ secondary to disarticulation ((b)(4) could not be concluded, although the reported squeaking upon weightbearing 4 days post-primary tha could have indicated impingement.Additionally, the patient¿s bmi, unknown adherence to post-operative restrictions, the multiple cultures and the use of antibiotic powder and beads during the 1st revision could have suggested infection; however, the pathology form indicated ¿no specimen¿ on (b)(6) 2017.Post-revision documentation notes that the pain persisted.((b)(4)).Dislocation ((b)(4)) and loosening ((b)(4)) are both included in the ¿possible adverse effects¿ which are noted in the ¿important medical information warnings/precautions total hip system¿/anthology surgical technique [71381440].The patient impact beyond the failed thas, symptoms/clinical findings and subsequent revisions could not be determined, although per x-ray 1 year post 2nd revision reported no change.A review of the manufacturing records did not reveal abnormalities that could have caused or contributed.We have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch.Based on this investigation, the need for corrective action is not indicated.A review of the risk management file and instructions for use document for this failure mode was conducted.Potential probable causes that could have contributed to the reported event include but are not limited to patient condition/reaction, and a post-operative healing issue.If new information is received, this complaint can be re-opened.

• Brand Name: ANTHOLOGY SO POROUS SIZE 6
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poektter ; 1450 brooks rd; memphis, TN 38116
• MDR Report Key: 7106651
• MDR Text Key: 94468678
• Report Number: 1020279-2017-01230
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71356006
• Device Lot Number: 17BM02373
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention