MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EMP STEM 9 SO 140MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number 71290902

Device Problems Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Deformity/ Disfigurement (2360); Implant Pain (4561)

Event Date 09/13/2021

Event Type  Injury  

Event Description

It was reported that, after a right thr on (b)(6) 2015 due to right hip osteoarthritis with limited range of motion, the patient experienced pain, groin tenderness, limited internal and external rotation.Ct scan showed prosthetic fracture of stem and x-rays confirmed broken stem displaced, fractured, and angulated at the level of the greater trochanter/intertrochanteric region.The patient underwent revision surgery on right hip on (b)(6) 2021.It is unknown the status of the patient.

Manufacturer Narrative

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

Manufacturer Narrative

Internal complaint reference number: (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, smith and nephew has not received the explanted devices or adequate patient-specific 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.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 instructions for use documents for hip systems revealed that implant fracture has been identified as a 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 but not limited to traumatic injury or surgical technique.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

H3, h6: the associated device was returned and evaluated.The visual inspection revealed complete fracture of the stem.A laboratory analysis performed on the device revealed bony ingrowth on proximal portion of femoral stem with possible extraction damage.No deviations from processing or material specifications were noted for any of the components.From visual observation and information provided, no conclusions can be made as to what initiated the fatigue fracture.The clinical/medical investigation concluded that, the provided x-rays were reviewed, confirm the reported prosthetic fracture of stem.The clinical root cause of the reported stem fracture cannot be definitively concluded; however, the reported rollover golf cart accident can¿t be ruled out as a contributing factor to the prosthetic fracture of stem and subsequent revision.At 2-months post revision it was noted, the patient was doing very well.No further clinical assessment is warranted at this time.A review of the production order 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 instructions for use documents for total hip systems revealed implant fracture as a probable cause of patients who are young, physically active, and/or heavy, this 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.According with the inspection procedure, the final inspection includes the verification of part configuration per print.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.A factor that could contribute to the reported event include traumatic injury.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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: EMP STEM 9 SO 140MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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: 14212753
• MDR Text Key: 290105466
• Report Number: 1020279-2022-01979
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 03596010561275
• UDI-Public: 03596010561275
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052426
• 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,Followup,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2023
• Device Model Number: 71290902
• Device Catalogue Number: 71290902
• Device Lot Number: 13BM16882A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2013
• 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: COCR 12/14 FEM HEAD 32 + 0, 14LM09267; COCR 12/14 FEM HEAD 32 + 0,14LM09267; COCR 12/14 FEM HEAD 32 + 0-14LM09267; EMP SLV 9 SM CONE 2 SPOUT, 14GSL0014A; EMP SLV 9 SM CONE 2 SPOUT, 14GSL0014A; EMP SLV 9 SM CONE 2 SPOUT-13BM16882A; PRO NON-POR TB BASE RT S3, 10AM10691; R3 0 DEGREE XLPE LNR 32MM X 54MM, 15AM06290; R3 0 DEGREE XLPE LNR 32MM X 54MM,15AM06290; R3 0 DEGREE XLPE LNR 32MM X 54MM-15AM06290; R3 0 HOLE ACET SHELL 54MM, 15AM06290; R3 0 HOLE ACET SHELL 54MM, 15AM06290; REF THREADED HOLE COVER; REF THREADED HOLE COVER, 14LM09267; REF THREADED HOLE COVER, 14LM09267
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male