MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM UNI 12/14 TPR SLV + 4; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71326604

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

Patient Problems Failure of Implant (1924); Pain (1994); Pocket Erosion (2013); Joint Dislocation (2374); Metal Related Pathology (4530)

Event Date 01/07/2019

Event Type  Injury  

Manufacturer Narrative

Complaint reference: case-(b)(4).

Event Description

It was reported that a revision surgery was performed on the patient left hip on (b)(6) 2020.The revision surgery was performed due to increasingly painful left hip; failed left revision total hip replacement with extensive metalosis.The patient outcome is unknown.

Manufacturer Narrative

H3, h6: it was reported that right hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.As no device batch numbers were provided for investigation, a manufacturing record, complaint history and device labelling / instructions for use review could not be performed.If more information is received, this investigation will be reopened.A risk management review was performed.No additional risks were identified as result of the reported event.Smith and nephew has not received the device/ adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

Event Description

It was reported that a revision surgery was performed on the patient left hip on (b)(6) 2020.The revision surgery was performed due to increasingly painful left hip; failed left revision total hip replacement with extensive metallosis and recurrent dislocations.The patient´s first dislocation occurred on (b)(6) 2019 and was treated via open reduction.The second dislocation occurred on (b)(6) 2019 and was treated via closed reduction.

Manufacturer Narrative

H10: additional information in a2, b6, b7, d10, g4, h4.H11: corrected information in b3, b5, d1, d2a, d2b, d3, d4, d6a, g (contact office-manufacturing site), h6 (health effect - clinical code and health effect - impact code).

Event Description

It was reported that a revision surgery was performed on the patient left hip on (b)(6) 2020.The revision surgery was performed due to increasingly painful left hip; failed left revision total hip replacement with extensive metallosis and recurrent dislocations.The patient´s first dislocation occurred on (b)(6) 2019 and was treated via open reduction.The second dislocation occurred on (b)(6) 2019 and was treated via closed reduction.During the revision surgery, all the tha components were explanted and replaced with a system from a competitor.The patients¿ outcome is unknown.

Manufacturer Narrative

H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the clinical root cause of the reported dislocations and metallosis cannot be confirmed; however, the patient¿s history of osteoporosis, internal rotation of her leg and multiple falls cannot be ruled out as likely contributing factors to her dislocations and metallosis.With the information provided, the patient impact beyond the reported events cannot be concluded.No further assessment is warranted at this time.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 33 months and for the batch numbers based on historical data of the devices did not reveal similar events for the listed devices.For tandem uni 12/14 tpr slv + 4 and invis dist cent sz 8mm a review of the instructions for use documents for total hip systems revealed in warnings and precautions that the patient should be advised to report any pain and unusual incidences.Position changes in the components may compromise the durability of the implants.Also, although rare, metal sensitivity reactions and/or allergic reactions to foreign materials have been reported in patients following joint replacement, which have required device removal.Lastly, dislocation has been identified in warnings and precautions, that may result from improper selection of the neck length and cup, stem positioning, muscle looseness and/or malpositioning of components.For tandem unipolar 47mm a review of the instructions for use documents for endoprostheses systems revealed in adverse effects that acetabular pain and erosion have occurred when endoprostheses or unipolar and bipolar devices are used.Also, although rare, metal sensitivity reactions and/or allergic reactions to foreign materials can occur.Lastly, care must be taken to assess the viability of the acetabular hyaline cartilage and the presence of any irregularity, anomaly, or surface configuration which may predispose to subluxation and/or dislocation of the prosthesis as a warning.A review of the risk management files revealed these failure modes were previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to these products and event.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness, patient condition, postoperative care, implant corrosion, irregular implant interaction, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should the devices 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.

Manufacturer Narrative

H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the clinical root cause of the reported dislocations and metallosis cannot be confirmed; however, the patient¿s history of osteoporosis, internal rotation of her leg and multiple falls cannot be ruled out as likely contributing factors to her dislocations and metallosis.With the information provided, the patient impact beyond the reported events cannot be concluded.No further assessment is warranted at this time.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 37 months and for the batch numbers based on historical data of the devices did not reveal similar events for the listed devices.For tandem uni 12/14 tpr slv + 4 and invis dist cent sz 8mm a review of the instructions for use documents for total hip systems revealed that dislocation has been identified in warnings and precautions, that may result from improper selection of the neck length and cup, stem positioning, muscle looseness and/or malpositioning of components, failure to observe the warnings and precautions, trauma, strenuous activity, implant alignment, patient non-compliance, involuntary muscular disorders, improper or duration of service increase the risk of loosening.Also, it is state in the adverse events section that with all joint replacements, asymptomatic, localized, progressive bone resorption (osteolysis) may occur around the prosthetic components as a consequence of foreign body reaction to particulate wear debris.Osteolysis can lead to future complications necessitating the removal or replacement of prosthetic components.For tandem unipolar 47mm a review of the instructions for use documents for endoprostheses systems revealed in warnings that care must be taken to assess the viability of the acetabular hyaline cartilage and the presence of any irregularity, anomaly, or surface configuration which may predispose to subluxation and/or dislocation of the prosthesis as well as loosening of the components.A review of the risk management files revealed these failure modes were previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to these products and event.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness, patient condition, postoperative care, implant corrosion, irregular implant interaction, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should the devices 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.Corrected data: h6 (health effect - clinical code & health effect - impact code).

Manufacturer Narrative

H10- additional information.A4- patient weight.D10- concomitant medical products.H6- evaluation codes h11- corrected data.B5- describe event or problem.B7- other relevant history, including preexisting medical conditions.E1- initial reporter name.

Event Description

It was reported that, after undergoing left hip hemiarthroplasty on (b)(6) 2008 due to femoral neck fracture, the patient experienced tha dislocation and suspicion of infection.This event was solved by conducting an open hip reduction with aspiration on (b)(6) 2019, after which infection was ruled out (hip synovial biopsy).The patient then presented a second dislocation on (b)(6) 2019, for which a close reduction was performed.The patient subsequently suffered stem loosening along with severe femoral osteolysis and impending fracture.These complications were treated by performing a revision surgery on (b)(6) 2020, upon which large hip fluid collection was found in conjunction with no soft tissue attachment on the proximal femur and acetabular concentric erosion.Conversion to total hip replacement was performed by placing a competitor¿s (zimmer-biomet) tha system in exchange.The patient left the operating room in stable condition.

• Brand Name: TANDEM UNI 12/14 TPR SLV + 4
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 11240866
• MDR Text Key: 229092149
• Report Number: 3005975929-2021-00055
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010196569
• UDI-Public: 03596010196569
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2018
• Device Model Number: 71326604
• Device Catalogue Number: 71326604
• Device Lot Number: 08GM05313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/08/2008
• 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
• Treatment: 126647 / LOT#: 08HM05328; 71313208 / LOT#: 08FM03381; 71326604 / LOT#: UNKNOWN; IM HIP BN CMNT KIT(PN:121010, LN: 08ESM0042)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 65 KG