MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM UNIPOLAR 43MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL

Catalog Number	126643
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	10/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after undergoing hip hemiarthroplasty on (b)(6) 2023, the patient presented pain in the acetabulum.It was stated that pain was experienced due to activity and not because of any implant malfunction.This event was treated with a conversion to total hip arthroplasty on (b)(6) 2023, in which the 43mm tandem unipolar head was removed and the primary femoral stem remained in situ.Patient¿s current health status is unknown.
Additional Manufacturer Narrative
H10: internal complaint reference case-(b)(4).
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the reported pain.Additionally, it was reported the patient experienced pain during activity and the implants were not at fault.The patient impact was the reported pain and subsequent conversion to total hip arthroplasty.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for endoprostheses systems revealed in adverse effects that acetabular pain and erosion have occurred when endoprostheses or unipolar and bipolar devices are used.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A 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 specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness, patient condition or postoperative care.Based on this investigation, the need for corrective action is not indicated.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 43MM
• 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: 18139589
• Report Number: 1020279-2023-02235
• Device Sequence Number: 7999310
• Product Code: LZY
• UDI-Device Identifier: 03596010079725
• UDI-Public: 03596010079725
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K211176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2024

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: 126643
• Device Lot Number: 21JM20698
• 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: 10/27/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 01/15/2024
• Date Device Manufactured: 09/30/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female