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

Catalog Number	71322046
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a dislocated bipolar hip, on (b)(6) 2019 surgeon tried to reduce the hip and head dissociated from the tandem bipolar shell.On (b)(6) 2019 a revision surgery was performed, implants were removed and replaced.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and the provided x-rays confirm the reported dislocation; however, they do not provide a reason/root cause for the dislocation.Without the requested clinical relevant documents we are unable to conduct a thorough medical assessment.Therefore, no medical assessment is warranted at this time.This complaint will be re-evaluated if more information becomes available.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: TANDEM BIPOLAR COCR 46OD 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: 8559682
• Report Number: 1020279-2019-01695
• Device Sequence Number: 11310626
• Product Code: KWY
• UDI-Device Identifier: 03596010492456
• UDI-Public: 03596010492456
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K023743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2019

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 Catalogue Number: 71322046
• Device Lot Number: 17DM13295
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 04/28/2019
• Supplement Report FDA Received Date: 11/02/2019
• 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