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

Model Number 71322046

Device Problem Detachment Of Device Component (1104)

Patient Problem Pain (1994)

Event Date 05/03/2017

Event Type  Injury  

Event Description

It was reported a revision surgery was required due to hip pain.It was discovered the poly liner and femoral head had disassociated.

Manufacturer Narrative

Please review attached for the investigation results.(b)(4).

Manufacturer Narrative

This complaint has been reopened upon receipt of the patient¿s additional medical records.The associated tandem cocr shell liner and cobalt chrome femoral head were returned and previously evaluated.Our clinical investigation concluded that based on the information provided, the root cause of the dislocation and disassociation of the femoral head from the bipolar cup cannot be concluded.The patient impact beyond the reported pain and revision hemi-arthroplasty cannot be determined.A review of complaint history on the listed parts revealed no additional complaints for this failure mode with the same batch number.No further medical assessment is warranted.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: TANDEM BIPOLAR COCR 46OD 28ID
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: yagna angirish ; 1450 brooks rd; memphis, TN 38116
• MDR Report Key: 6668513
• MDR Text Key: 78441953
• Report Number: 1020279-2017-00474
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 03596010492456
• UDI-Public: 03596010492456
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2018

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: Health Professional
• Device Model Number: 71322046
• Device Catalogue Number: 71322046
• Device Lot Number: 17AM04012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2017
• Initial Date FDA Received: 06/26/2017
• Supplement Dates Manufacturer Received: 06/03/2017; 06/03/2017
• Supplement Dates FDA Received: 09/29/2017; 04/10/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention