MAUDE Adverse Event Report: SMITH & NEPHEW, INC. POLARSTEM METAL BALL HEAD 28 +3.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 71342803

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Injury (2348); Impaired Healing (2378); Inadequate Osseointegration (2646); Joint Laxity (4526)

Event Date 04/15/2020

Event Type  Injury  

Event Description

It was reported that a revision surgery with change of head and insert was being performed due to luxation.Implantation was carried out on (b)(6) 2020 with hi cup size 5, standard pe insert, oxinium ball head 28-3, polarstem size 3.It's unknown if there was a delay or how was the procedure finished.The state of the patient is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

(unique identifier (udi) #).Results of investigation: it was reported that a revision surgery with change of head and insert was being performed due to luxation.The affected device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A medical analysis noted that the operative reports were submitted along with an x-ray with the original nail in situ which supports the report of the broken compression screws.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Poor bone quality could have contributed to the reported issue.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the provided information does not reveal a root cause for the ¿pseudarthrosis and hip head necrosis¿ nor for the root cause for the ¿luxations¿ post the second revision.Poor bone quality could have contributed to both issues.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.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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.

• Brand Name: POLARSTEM METAL BALL HEAD 28 +3.5
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10063416
• MDR Text Key: 191228997
• Report Number: 1020279-2020-01757
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K021673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71342803
• Device Lot Number: 19MM14117
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention