MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 44MM COCR MODULAR HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number 71342644

Device Problem Biocompatibility (2886)

Patient Problems Hip Fracture (2349); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 08/24/2021

Event Type  Injury  

Event Description

Us legal bilateral patient.It was reported that after the patient underwent a revision surgery of the left hip on (b)(6) 2012, the patient underwent another revision surgery of the left hip on (b)(6) 2021 due to mechanical complication of prosthetic hip implant, osteolysis, metallosis and periprosthetic fracture.The primary left bhr was performed on (b)(6) 2009.The patient status is unknown.

Manufacturer Narrative

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

Manufacturer Narrative

H3, h6.The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, with the information provided the clinical root cause of the reported elevated metal ions and intraoperative findings of metallosis, trunnionosis and greater trochanteric fracture cannot be confirmed.However, the surgical technique indicates the acetabular component is to be impacted with 15-20° of anteversion.The implantation operative report indicated the acetabular component was implanted at about 20 to 25 degrees of anteversion.It is unknown if the increased anteversion of the acetabular component led to the reported elevated metal ions and intraoperative findings of metallosis and trunnionosis.It cannot be concluded that the reported events/ clinical reactions were associated with a mal performance of the implant.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems revealed that fracture, metal sensitivity reactions and/or allergic reactions to foreign materials has been identified as adverse events in primary and revision surgery.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.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.Some potential probable causes for this event could include surgical technique, excessive forces applied to the implant, damaged product, implant corrosion or wear.The contribution of the device to the reported event could not be corroborated.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.

Manufacturer Narrative

The devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that with the information provided the clinical root cause of the reported elevated metal ions and intraoperative findings of metallosis, trunnionosis and greater trochanteric fracture cannot be confirmed.However, the surgical technique indicates the acetabular component is to be impacted with 15-20° of anteversion.The implantation operative report indicated the acetabular component was implanted at about 20 to 25 degrees of anteversion.It is unknown if the increased anteversion of the acetabular component led to the reported elevated metal ions and intraoperative findings of metallosis and trunnionosis.It cannot be concluded that the reported events/clinical reactions were associated with a mal performance of the implant.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.The devices batch numbers were not provided, thus, an evaluation of the manufacturing records could not be performed.Also, for the anthology hip implant, as the device specific identifiers were not provided, an evaluation of the complaint history review, risk management file, and prior actions could not be performed.For the cocr modular head, a review of complaint history for 36 months did not reveal similar events for the listed device.For the titanium modular head, a review of complaint history for 36 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for total hip systems reveals in the warnings and precautions section that congenital deformity, improper implant selection, improper broaching or reaming, osteoporosis, bone defects due to misdirected reaming, trauma, strenuous activity, improper implant alignment or placement, patient non-compliance, etc.Can increase risk of femoral or pelvic fractures.It also reveals in the adverse events in primary and revision surgery 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.Particles are generated by interaction between components, as well as between the components and bone, primarily through wear mechanisms of adhesion, abrasion, and fatigue.Secondarily, particles may also be generated by third-body particles lodged in the polyethylene, metal, or ceramic articular surfaces.Osteolysis can lead to future complications necessitating the removal or replacement of prosthetic components.Besides, it reveals in the postoperative warnings and precautions section that the patient should be advised to report any decrease in range of motion, squeaking, clicking, popping, grating, or grinding noises, and unusual incidences.For the cocr modular head and the titanium modular head, a review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.Besides, a historical review concluded that there are no prior actions related to these products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include implant corrosion, irregular implant interaction, wear, abnormal motion over time, patient condition, traumatic injury, patient medical history, and/or bone quality.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.

• Brand Name: 44MM COCR MODULAR HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• 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: 13896710
• MDR Text Key: 288318219
• Report Number: 1020279-2022-01337
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010652010
• UDI-Public: 03596010652010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71342644
• Device Catalogue Number: 71342644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: No
• 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: 57 YR
• Patient Sex: Male