MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM BIPOLAR COCR 42OD 22ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number	71322042
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a hip hemiarthroplasty, when reducting the hip, with all implants in place, the cocr 12/14 fem head 22 + 0 disassociate from the tandem bipolar cocr 42od 22id and stayed on the stem.Surgeon removed head from stem and put those implants back together and tried again, but it happened again.On the second time of trying to remove the head from the stem, the whole stem came out.Surgeon had to place new stem and new tandem implants.The procedure was completed with a delay greater than 30min using a smith-nephew back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.Therefore, product analysis could not be performed at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.Factors and/or potential causes that could contribute to the reported event could include alignment or surgical technique.A relationship, if any, between the device and the reported incident could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: TANDEM BIPOLAR COCR 42OD 22ID
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11332950
• Report Number: 1020279-2021-01369
• Device Sequence Number: 16754027
• Product Code: KWY
• UDI-Device Identifier: 03596010492418
• UDI-Public: 03596010492418
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/23/2024
• Device Model Number: 71322042
• Device Catalogue Number: 71322042
• Device Lot Number: 14LM16987
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 05/29/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 05/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1