MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTL ALUM CER 28MM HD 12/14 +0; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Catalog Number 71332800

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 02/01/2019

Event Type  Injury  

Event Description

It was reported that the patient's ball head is broken.A revision surgery was performed on the patient to correct the adverse event.Broken device was replaced with a smith & nephew's implant.

Manufacturer Narrative

The associated complaint device was not returned.The two undated, unlabeled x ray provided demonstrate a shift of the femoral neck in alignment with the shell and debris around the femoral neck which supports the complaint.However, without the request clinical information, operative reports, fall history, length of time in situ or bone quality we are unable to determined the root cause of the broken ball head.The future impact to the patient cannot be determined.Should any relevant clinical information become available this case will be re evaluated.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re opened.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: patient information surgical procedure/post-operative care review.Device labeling (including technique guides, ifus, etc.) this case reports this 67 year old male underwent a right hip revision due to necrosis of the right femoral head (captured under (b)(4)).However, no information has been provide for inclusion in this investigation.Conclusion: ((b)(4)) without report of implanted devices and if the ball head was prosthetic (which wouldn¿t be able to necrose), a medical investigation cannot be performed.No further clinical/medical assessment is warranted at this time.Per report approximately four years later, after two days with no cause of right hip pain and inability to tolerate walking, it was reported the patient was admitted to the hospital and x-rays reportedly showed a broken ball head.The patient underwent a second revision due to a broken ball head.It was reported the revision was performed to correct the adverse event.The broken device was replaced with a smith & nephew's implant (captured under (b)(4)).Only two undated, unlabeled x-ray photos were provided demonstrate a shift of the femoral neck in alignment with the shell and debris around the femoral neck which supports the complaint.Conclusion: ((b)(4)) the two undated, unlabeled x-ray provided demonstrate a shift of the femoral neck in alignment with the shell and debris around the femoral neck which supports the complaint.However, without the request clinical information, operative reports, fall history, length of time in-situ or bone quality we are unable to determined the root cause of the broken ball head.The future impact to the patient cannot be determined.Should any relevant clinical information become available this case will be re-evaluated.No further assessment is warranted at this time.Approved by (b)(6) md on 3/20/2019.Mimb review: assess severity of complaint case to determine if additional action and further inputs are required for inclusion in medical assessment.Determine if a medical assessment would be performed based on a review of the complaint detail and further recommendations from the medical director/designee.Reviewed during mimb.A medical investigation will be performed.Proceed based on information provided/available for the investigation; if no relevant clinical information is provided, recommend closure.Approved by (b)(6), medical director.This case reports this 67 year old male underwent a right hip revision due to necrosis of the right femoral head (captured under (b)(4)).However, no information has been provide for inclusion in this investigation.Conclusion: ((b)(4)) without report of implanted devices and if the ball head was prosthetic (which wouldn¿t be able to necrose), a medical investigation cannot be performed.No further clinical/medical assessment is warranted at this time.Per report approximately four years later, after two days with no cause of right hip pain and inability to tolerate walking, it was reported the patient was admitted to the hospital and x-rays reportedly showed a broken ball head.The patient underwent a second revision due to a broken ball head.It was reported the revision was performed to correct the adverse event.The broken device was replaced with a smith & nephew's implant (captured under (b)(4)).Only two undated, unlabeled x-ray photos were provided demonstrate a shift of the femoral neck in alignment with the shell and debris around the femoral neck which supports the complaint.Conclusion: ((b)(4)) the two undated, unlabeled x-ray provided demonstrate a shift of the femoral neck in alignment with the shell and debris around the femoral neck which supports the complaint.However, without the request clinical information, operative reports, fall history, length of time in-situ or bone quality we are unable to determined the root cause of the broken ball head.The future impact to the patient cannot be determined.Should any relevant clinical information become available this case will be re-evaluated.No further assessment is warranted at this time.Approved by (b)(6) md on 3/20/2019.

• Brand Name: INTL ALUM CER 28MM HD 12/14 +0
• Type of Device: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8368341
• MDR Text Key: 137082839
• Report Number: 1020279-2019-00790
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03596010385338
• UDI-Public: 03596010385338
• Combination Product (y/n): N
• PMA/PMN Number: K981847
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/09/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 71332800
• Device Lot Number: 15AM03674
• Initial Date Manufacturer Received: 02/01/2019
• Initial Date FDA Received: 02/25/2019
• Supplement Dates Manufacturer Received: 06/07/2019
• Supplement Dates FDA Received: 06/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 60