MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM BIPOLAR COCR 50OD 28ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number	71322050
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374); No Code Available (3191)
Date of Event	04/23/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was repored that the patient was admitted to er with dislocated hip.After unsuccessful attempt to relocate the hip a revision surgery was performed.Per report x-ray showed that the head had dislocated from the liner and the liner was also dislocated.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: TANDEM BIPOLAR COCR 50OD 28ID
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6580947
• Report Number: 1020279-2017-00357
• Device Sequence Number: 616514
• Product Code: KWY
• UDI-Device Identifier: 03596010492494
• UDI-Public: 03596010492494
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 09/20/2017

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 Expiration Date: 05/26/2025
• Device Catalogue Number: 71322050
• Device Lot Number: 15EM19603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Initial Date Received by Manufacturer: 04/24/2017
• Supplement Date Received by Manufacturer: 04/24/2017
• Initial Report FDA Received Date: 05/22/2017
• Supplement Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COCR FEM HD GT 28OD +0, (B)(4)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention