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

Model Number 71324046

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rupture (2208)

Event Date 12/07/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).Initial reporter name and address: postal code: (b)(6).

Event Description

It was reported that, after a partial arthroplasty had been performed on an unspecified date to repair a femur fracture, the patient had two consecutive falls afterwards, which caused tears in all soft tissue support structures around the hip joint.Redapt slvls mono stem 240mm sz 17 so, cocr 12/14 fem head 28 +0 and tandem intl bipolar 46od 28id were explanted.Patient outcome is unknown.

Event Description

It was reported that, after a partial arthroplasty had been performed on (b)(6) 2021 to repair a femur fracture, the patient had two consecutive falls afterwards, which caused tears in all soft tissue support structures around the hip joint.Redapt slvls mono stem 240mm sz 17 so, cocr 12/14 fem head 28 +0 and tandem intl bipolar 46od 28id were explanted.The patient was left with a gurdle stone hip.The patient current health status is good.

Manufacturer Narrative

Internal reference number: (b)(4).

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that without the requested clinical information or the device, a thorough medical investigation cannot be rendered nor can the root cause of the reported failure be confirmed.However, we cannot rule out the reported ¿two consecutive falls, which caused tears in all soft tissue support structures around the hip joint,¿ as likely contributory factors.The impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Per email correspondence, the ¿surgeon does not see this as a product complaint as the incident is not product related.¿ therefore, no further medical assessment is warranted at this time.Should any additional relevant clinical information be provided, this complaint would be re-assessed.A review of the manufacturing records 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 risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.The instructions for use documents revealed this failure mode was previously identified.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 product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury or patient anatomy.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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 INTL BIPOLAR 46OD 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: 13089690
• MDR Text Key: 282796935
• Report Number: 1020279-2021-08858
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 03596010494375
• UDI-Public: 03596010494375
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K023743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71324046
• Device Catalogue Number: 71324046
• Device Lot Number: R2014517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2020
• 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