MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM BIPOLAR COCR 49OD 28ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number 71322049

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Dislocation (2374)

Event Date 02/01/2021

Event Type  Injury  

Event Description

It was reported that, patient had a hemiarthroplasty and had two previous dislocations, due to a third dislocation surgeon decided to remove the cocr 12/14 fem head 28 +0 and the tandem bipolar cocr 49od 28id and put in cup and liner to covert to a total hip.Outcome is unknown.

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, per complaint details, a 98-year old patient experienced three dislocations post hemiarthroplasty and required revision approximately 2 months post implantation.Reportedly, the surgeon decided to revise/convert the hemi-construct to a tha with a cup and liner.Per correspondence, explants are not being returned because the bipolar shell and head were sent to pathology per hospital requirements.Requested clinically relevant documentation had not been provided as of the date of this investigation; therefore, the root cause of the reported event(s) could not be full assessed nor concluded.Based on the information provided, the patient impact beyond the reported dislocations and subsequent revision could not determined.No further medical assessment could be rendered at this time.Should additional information/documentation become available, the clinical/medical task may be re-opened for further evaluation.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.We consider this investigation closed.

• Brand Name: TANDEM BIPOLAR COCR 49OD 28ID
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11388912
• MDR Text Key: 233897381
• Report Number: 1020279-2021-01624
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 03596010492487
• UDI-Public: 03596010492487
• 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: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71322049
• Device Catalogue Number: 71322049
• Device Lot Number: 20DM11641
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention