MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM BIPOLAR COCR 43OD 28ID; PRSTHS,HIP,HMI,FMRL,MTL/PLYMER,CEMENTED OR UNCEMENTED

Catalog Number 71322043

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Injury (2348)

Event Date 04/28/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to dislocation.

Manufacturer Narrative

The associated complaint devices were returned and evaluated.A visual inspection of the returned bi-polar component was returned assembled with internal polyethylene components fully locked in place.Visually no damage to the component was observed.Visual examination on the head component did not find any damage.The head was place in the opening of the bi-polar component through which it would have had to pass in order to disassemble.This demonstrates the head diameter was large enough to be constrained within the bi-polar component as designed.No deviations of material or manufacturing process are indicated for these components.No conclusions as to the cause of this issue can be determined.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 for the listed parts did not reveal additional complaints for the listed batches.Based on this investigation, the need for corrective action is not indicated.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.We consider this investigation closed.

• Brand Name: TANDEM BIPOLAR COCR 43OD 28ID
• Type of Device: PRSTHS,HIP,HMI,FMRL,MTL/PLYMER,CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7509003
• MDR Text Key: 108079580
• Report Number: 1020279-2018-00911
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 03596010492425
• UDI-Public: 03596010492425
• 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: 11/18/2018

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: Physician
• Device Catalogue Number: 71322043
• Device Lot Number: 17MM01521
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/28/2018
• Initial Date FDA Received: 05/11/2018
• Supplement Dates Manufacturer Received: 04/28/2018
• Supplement Dates FDA Received: 11/18/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR