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

Model Number	71324050
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	05/02/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Additional 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.
Additional Manufacturer Narrative
Additional information added: d4 (lot number), h4.Corrected data: b5.
Event or Problem 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
• 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: 15129321
• Report Number: 1020279-2022-03460
• Device Sequence Number: 20483818
• Product Code: KWY
• UDI-Device Identifier: 03596010494412
• UDI-Public: 03596010494412
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K023743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2022

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?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 08/08/2022; 09/07/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 08/15/2022; 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• 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 Age: 89 YR
• Patient Sex: Male
• Patient Weight: 80 KG