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

Model Number	71322046
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/03/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery was required due to hip pain.It was discovered the poly liner and femoral head had disassociated.
Additional Manufacturer Narrative
Please review attached for the investigation results.(b)(4).
Additional 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
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6668513
• Report Number: 1020279-2017-00474
• Device Sequence Number: 1882177
• Product Code: KWY
• UDI-Device Identifier: 03596010492456
• UDI-Public: 03596010492456
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K023743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 06/03/2017
• Supplement Date Received by Manufacturer: 06/03/2017; 06/03/2017
• Initial Report FDA Received Date: 06/26/2017
• Supplement Report FDA Received Date: 09/29/2017; 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention