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 Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a left hip hemiarthroplasty performed due to medial dislocated femoral neck fracture, it became apparent that the connection of a tandem intl bipolar 46od 28id; between the inlay and the ring was inadequate.The inlay would come loose at the slightest touch/twist, and the metal ring did not close as usual (apparently too large).The procedure was resumed, after a non-significant delay, with a size 44 tandem with a 28 xs head.Patient was not harmed as a consequence of this problem.
Additional Manufacturer Narrative
Internal complaint reference:(b)(4).H7: following the initial investigative actions performed on the returned sample associated to this incident, smith+nephew (s+n) has confirmed a manufacturing issue associated to the assembly of an oversized retainer ring in the product which results in a reduced retention force of the bipolar assembly.Consequently, s+n has initiated a field action on (b)(6) 2024 to voluntarily remove the batch w2401399 of tandem intl bipolar 46od 28id.
Additional Manufacturer Narrative
Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions), h9 (fda recall number).Results of investigation: the alleged device was returned and evaluated.The visual inspection, conducted by naked eye, does not reveal any defects.However, a dimensional evaluation performed on the device revealed that the retaining ring showed a size bigger than intended.A review of the production records concluded that a larger retaining ring was used instead of the adequate one.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.A review of the risk management file revealed this failure mode was previously identified.A historical review concluded that there were no prior actions related to this product and event.The provided intraoperative fluoroscopy was reviewed; however, the image does not show the inlay and locking ring.The patient impact is determined to be a surgical delay of 25-30 minutes and the implantation of a smaller tandem bipolar.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.This issue was identified and is being addressed though our internal quality process, and a removal was previously issued.Should 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 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: 20487471
• Report Number: 1020279-2024-02149
• Device Sequence Number: 4174217
• Product Code: KWY
• UDI-Device Identifier: 03596010494375
• UDI-Public: 03596010494375
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K023743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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
• Device Catalogue Number: 71324046
• Device Lot Number: W2401399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 01/07/2025
• 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
• Patient Sex: Female