MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM UNIPOLAR 54MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL

Model Number	126654
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that, after a thr surgery performed on ((b)(6) 2021), due to infection a two stages revision surgery was performed.On the first stage the tandem unipolar head 54mm (case (b)(4)), the tandem unipolar 12/14 taper sleeve + 0 (case (b)(4)) and the spectron ef 12/14 taper long straight 225mm small (case (b)(4)) were explanted and a revision long stem spectron with a tandem unipolar head, coated in antibiotic cement were placed into the patient.The second stage revision surgery was performed on (b)(6) 2021 to extract the devices that were put in on the first stage surgery and to exchange them with the implants.Current health status of the patient is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that, the two undated photos of x-rays were reviewed.However, they do not aid in the clinical investigation of the reported infection.Therefore, based on insufficient information, a thorough medical assessment could not be performed at this time.Should any additional relevant clinical information be provided, this complaint would be re-assessed.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 complaint history did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.The instructions for use documents revealed this failure mode was previously identified.A review of the sterilization records revealed the batch was sterilized within normal parameters.An historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.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 is 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 UNIPOLAR 54MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13012873
• Report Number: 1020279-2021-08687
• Device Sequence Number: 1893688
• Product Code: LZY
• UDI-Device Identifier: 03596010079831
• UDI-Public: 03596010079831
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K896580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2022

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: 04/01/2022
• Device Model Number: 126654
• Device Catalogue Number: 126654
• Device Lot Number: 12DM01706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown