MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM BIPOLAR COCR 57OD 28ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number	71322057
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the bipolar hip prosthesis disengaged after patient had a fall.A revision surgery was performed.The tandem bipolar and the femoral head were removed.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, it was reported that the bipolar hip prosthesis disengaged after patient had a fall.A revision surgery was performed.No clinical documentation has been provided.Beyond the revision no additional patient impact is known.No further clinical investigation is warranted at this time based on the limited information provided.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: TANDEM BIPOLAR COCR 57OD 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: 8504714
• Report Number: 1020279-2019-01505
• Device Sequence Number: 193227
• Product Code: KWY
• UDI-Device Identifier: 03596010492555
• UDI-Public: 03596010492555
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K023743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2019

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: 10/26/2025
• Device Catalogue Number: 71322057
• Device Lot Number: 15KM20739
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 10/18/2019
• 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