MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 44OD 28ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number 71324044

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 09/24/2019

Event Type  Injury  

Event Description

It was reported that despite what seemed to be a satisfactory implantation, a revision surgery had to be done due to dislocation.The bipolar cup was dislocated and did not have the head inside it when the parts where removed, despite having the integral and well placed safety ring.New devices of the same reference were place as replacement.Back-up available, no delay reported.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device is heavily worn with nicks and scratches in all surfaces.The lock ring on the device is deformed with indentions around the inner edges showing impingement with the mating stem.The deformation is likely from the head being shucked out during the attempted joint reduction.The device was manufactured in 2018.The medical investigation concluded that, per the product evaluation, the stated failure mode could not be confirmed.No change to the previous medical investigation (b)(4) is otherwise warranted at this time, as clinical/medical supporting documentation has not been provided as of this date.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A dimensional inspection was attempted but the device was too damaged to obtain accurate measurements.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes for this event could include a fit/sizing issue or a traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should 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.

Manufacturer Narrative

It was reported that a revision surgery had to be done due to dislocation.The bipolar cup was dislocated and did not have the head inside it when the parts were removed.The associated tandem bipolar and cobalt chrome femoral head, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Possible causes could include but not limited to user/procedural variance or surgical technique used.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved and no patient medical history, our investigation of this report is inconclusive.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, the complaint will be reopened.

• Brand Name: TANDEM INTL BIPOLAR 44OD 28ID
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9216074
• MDR Text Key: 163114187
• Report Number: 1020279-2019-03692
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 03596010494351
• UDI-Public: 03596010494351
• Combination Product (y/n): N
• PMA/PMN Number: K023743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71324044
• Device Catalogue Number: 71324044
• Device Lot Number: 18AW23200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Date Manufacturer Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 52