MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECHELON PP HA SZ 11 190MM; PROSTHESIS,HIP,SEMICONSTRAINED,UNCEMENT,METALPOLYMER,NONPOROU,CALICUMPHOSPHATE

Model Number 71340111

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 09/27/2018

Event Type  Injury  

Event Description

It was reported that the patient stood up from a seating position, and felt the hip fail "with a load noise", and implant fractured.

Manufacturer Narrative

The associated echelon stem along with the oxinium femoral head and an unidentified instrument were returned and evaluated.A lab analysis conducted during this investigation indicated that the returned femoral stem was found to be fractured at a distal distance of approximately 95 mm from the head center.Scratches were observed on the femoral neck surface, more than likely occurred during extraction.Bone integration was observed on the proximal-lateral porous region and on the porous region of the collar.The distal piece of the stem shows bone integration in the porous region as well.The distal portion was returned with the removal instrument firmly attached and will require destructive testing in order to separate the two.The oxinium femoral head appears to be 32 mm in diameter with no signs of damage.A clinical analysis noted that the weakened structure of the incompletely healed left proximal femoral fractures, lack of bony support around the proximal stem and a possible low seating position are likely contributing factors to the reported stem fracture.The patient impact beyond the reported stem fracture, probable pain/discomfort, revision procedure and an expected post-operative convalescence period cannot be determined.No further medical assessment can be rendered at this time.Our investigation included a review of complaint history for the stem which revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

Manufacturer Narrative

The associated echelon stem along with the oxinium femoral head and an unidentified instrument were returned and evaluated.A lab analysis conducted during this investigation indicated that the returned femoral stem was found to be fractured at a distal distance of approximately 95 mm from the head center.Scratches were observed on the femoral neck surface, more than likely occurred during extraction.Bone integration was observed on the proximal lateral porous region and on the porous region of the collar.The distal piece of the stem shows bone integration in the porous region as well.The distal portion was returned with the removal instrument firmly attached and will require destructive testing in order to separate the two.The oxinium femoral head appears to be 32 mm in diameter with no signs of damage.A clinical analysis noted that the weakened structure of the incompletely healed left proximal femoral fractures, lack of bony support around the proximal stem and a possible low seating position are likely contributing factors to the reported stem fracture.The patient impact beyond the reported stem fracture, probable pain/discomfort, revision procedure and an expected post operative convalescence period cannot be determined.No further medical assessment can be rendered at this time.Our investigation included a review of complaint history for the stem which revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: ¿patient information ¿surgical procedure/post-operative care review ¿device labeling (including technique guides, ifus, etc.) re-opened as a us legal complaint.No new clinical documentation has been provided; therefore, no changes to the previously approved mi report is warranted at this time.Please refer to the approved updated mi report attached in the first issue# i-0208773.No new clinical documentation has been provided; therefore, no changes to the previously approved mi report is warranted at this time.Please refer to the approved updated mi report attached in the first issue# i-0208773.

Manufacturer Narrative

The devices, used in treatment, was returned for evaluation.A lab analysis confirmed that the stem was fractured at a distal distance of 95 mm from center.Scratches were on the neck, likely from extraction.Bone integration was observed on the porous region, the collar, and the distal piece of the stem shows bone integration.The distal portion was returned with the removal instrument attached, requiring destructive testing to separate.The oxinium head appears to be 32 mm in diameter with no damage.Our clinical/medical team confirmed that the exact cause of the stem fracture could not be concluded.Muscle instability, the weakened structure of the incompletely healed left proximal femoral fractures, lack of bony support around the proximal stem and a possible low seating position are likely contributing factors.The patient impact beyond the reported stem fracture, pain/discomfort, revision procedure and an expected post-operative convalescence period could not be determined.Three months post-op 2nd revision was documented that the patient¿s ¿left hip looked good¿ and distal window was ¿filling in¿ with findings ¿consistent with left hip bursitis.¿ per newly provided documentation, the patient fell in 2019, which resulted in a left femoral stress fracture (per bone scan), and patient has experienced continued bursitis for which injections have been administered.Per the 12/04/2019 md notes, ¿hip is stable clinically and radiographically¿ with ¿most of his pain¿from bursitis or rectus tendinitis¿; plan to f/u every 2 years¿¿ it was noted that the patient was able to travel 12,000 miles via motorcycle riding in autumn 2019.A review of complaint history indicated no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the risk management file and instructions for use document for this failure mode was conducted.Factors and/or potential causes that could contribute to the reported event have been identified in the risk management file includes but not limited to procedural/user error, traumatic injury, and overuse.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Should additional information be received, the complaint will be reopened.

• Brand Name: ECHELON PP HA SZ 11 190MM
• Type of Device: PROSTHESIS,HIP,SEMICONSTRAINED,UNCEMENT,METALPOLYMER,NONPOROU,CALICUMPHOSPHATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7995289
• MDR Text Key: 124697232
• Report Number: 1020279-2018-02243
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 03596010328700
• UDI-Public: 03596010328700
• Combination Product (y/n): N
• PMA/PMN Number: K023302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/05/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 71340111
• Device Catalogue Number: 71342011
• Device Lot Number: 09CM16260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Initial Date Manufacturer Received: 09/27/2018
• Initial Date FDA Received: 10/23/2018
• Supplement Dates Manufacturer Received: 09/27/2018; 09/27/2018; 09/27/2018; 10/08/2019; 08/04/2020
• Supplement Dates FDA Received: 11/27/2018; 02/11/2019; 02/13/2019; 11/17/2019; 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN/ UNKNOWN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 78