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

Catalog Number	71324046
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Joint Dislocation (2374)
Date of Event	01/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, on (b)(6) 2024, the patient came in for a hemiarthroplasty where a tandem intl bipolar 46od 28id was implanted without complications.On (b)(6) 2025 the patient reported to ed and it was found that the implanted bipolar had disassociated.The patient's implant disassociated impacting their mobility and increasing their pain.The patient was brought in for a revision surgery on (b)(6) 2025.No other complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Results of investigation: the device was not returned for evaluation.The provided x-ray was reviewed and is consistent with reported disassociation, as the inner head is not centered within the outer head.The patient¿s increase in pain and impacted mobility is consistent with the reported disassociated bipolar head.A review of the production records concluded that a larger retaining ring was used during the assembly process.The root cause of this event was determined to be an error during assembly of the retaining ring in the tandem bipolar device during manufacturing.A field correction / removal has been issued for impacted devices.The underlaying hemiarthroplasty surgery was performed before awareness of the issue and the performed escalation actions.Should additional information be received, this complaint will be reopened.We consider this investigation closed.

• Brand Name: TANDEM INTL BIPOLAR 46OD 28ID
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• 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: 21217814
• Report Number: 1020279-2025-00159
• Device Sequence Number: 8786668
• Product Code: KWY
• UDI-Device Identifier: 03596010494375
• UDI-Public: 3596010494375
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K023743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71324046
• Device Lot Number: W2401399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2025
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0326-2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female