MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 50OD 28ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number 71324050

Device Problems Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374)

Event Date 05/02/2022

Event Type  Injury  

Event Description

It was reported that, after a thr surgery was performed on (b)(6) 2022, the patient experienced a tandem intl bipolar 50od 28id abnormal position, as it migrated horizontally making almost in direct contact with the femoral stem.This was confirmed upon conducting postoperative x-rays right after the surgery was concluded.On (b)(6) 2022, additional x-rays were taken where the dislocation of the bipolar prosthesis was evidenced, as the femoral head completely separated from the tandem intl bipolar 50od 28id construct.This adverse event was solved by a revision surgery on (b)(6) 2022.During this procedure, the tandem intl bipolar 50od 28id was removed and exchanged for an implant of another company.Current health status of patient is unknown.

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Manufacturer Narrative

H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.However three x-rays and one photo of the implant that were provided were reviewed and confirm the reported abnormal position of the cup, dislocation, and femoral head stuck to the stem.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.The clinical/medical evaluation concluded that with the limited information provided, the clinical root cause of the reported abnormal (horizontal) position of the cup, dislocation, and femoral head/cup construct separation cannot be definitively concluded.However, a user vs procedural variance and the reported possibility ¿that the selected size was not suitable for the patient's anatomy,¿ cannot be ruled out as contributing factors to the reported clinical events.The patient impact beyond the reported events and revision cannot be determined.Therefore, no further clinical/medical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.The contribution of the device to the reported incident could be corroborated as the device was found to be dislocated, and it was required a revision surgery to treat this event.Possible causes could include but not limited to traumatic injury, patient anatomy, abnormal loading of limb, or user vs procedural variance and size selection.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

Manufacturer Narrative

Additional information added: d4 (lot number), h4.Corrected data: b5.

Event Description

It was reported that, after a thr surgery was performed on (b)(6) 2022, the patient experienced a tandem intl bipolar 50od 28id abnormal position, as it migrated horizontally making almost in direct contact with the femoral stem.This was confirmed upon conducting postoperative x-rays right after the surgery was concluded.On (b)(6) 2022, additional x-rays were taken where the dislocation of the bipolar prosthesis was evidenced, as the femoral head completely separated from the tandem intl bipolar 50od 28id construct.This adverse event was solved by a revision surgery on (b)(6) 2022.During this procedure, the tandem intl bipolar 50od 28id was removed and exchanged for an implant of another company.The patient¿s health condition is stable.

• Brand Name: TANDEM INTL BIPOLAR 50OD 28ID
• Type of Device: 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: 15129321
• MDR Text Key: 296863111
• Report Number: 1020279-2022-03460
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 03596010494412
• UDI-Public: 03596010494412
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K023743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71324050
• Device Catalogue Number: 71324050
• Device Lot Number: P2128861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 80 KG