MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM BIPOLAR COCR 46OD 28ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number 71322046

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 04/05/2019

Event Type  Injury  

Event Description

It was reported that patient had a dislocated bipolar hip, on (b)(6) 2019 surgeon tried to reduce the hip and head dissociated from the tandem bipolar shell.On (b)(6) 2019 a revision surgery was performed, implants were removed and replaced.

Manufacturer Narrative

The associated complaint devices were not returned.A clinical evaluation was conducted and the provided x-rays confirm the reported dislocation; however, they do not provide a reason/root cause for the dislocation.Without the requested clinical relevant documents we are unable to conduct a thorough medical assessment.Therefore, no medical assessment is warranted at this time.This complaint will be re-evaluated if more information becomes available.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: TANDEM BIPOLAR COCR 46OD 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: 8559682
• MDR Text Key: 143376266
• Report Number: 1020279-2019-01695
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 03596010492456
• UDI-Public: 03596010492456
• Combination Product (y/n): N
• PMA/PMN Number: K023743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71322046
• Device Lot Number: 17DM13295
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention