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

Model Number	71324046
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed since the head was out of the bipolar ball head one day after primary surgery.Patient was in good condition.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to dislocation of the bipolar ball head one day after implantation.The affected tandem bipolar head, used in treatment, was returned and evaluated.A lab analysis conducted during this investigation noted that visual inspection showed the od did not exhibit any visual deformities.The rim of the poly locking ring displayed an indented area likely from contact with a femoral neck.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Based on this investigation, the need for corrective action is not indicated.Some potential causes of the reported event could include but not limited to user/procedural variance, surgical technique or size of device.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: TANDEM INTL BIPOLAR 46OD 28ID
• Common Device Name: PROSTHESISHIPHEMI-, FEMORAL METAL/POLYMER CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9586278
• Report Number: 1020279-2020-00252
• Device Sequence Number: 3461434
• Product Code: KWY
• UDI-Device Identifier: 03596010494375
• UDI-Public: 03596010494375
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2020

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: 71324046
• Device Catalogue Number: 71324046
• Device Lot Number: 19DW09446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 05/21/2020
• 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
• Patient Age: 71 YR
• Patient Weight: 56