MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 54MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Model Number 71335554

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

Patient Problems Inflammation (1932); Pain (1994)

Event Date 04/18/2018

Event Type  Injury  

Event Description

Us legal: it was reported that, the patient underwent a procedure trochanteric injection performed for a bursitis due to pain and femoral loosening of the prosthetic right hip.No further medical records have been received nor any additional revision surgery has been reported.Patient outcome unknown.

Manufacturer Narrative

H3, h6: the affected complaint device, used in treatment, was not returned for evaluation.Therefore, a product analysis could not be performed.There is no information that would suggest the device failed to meet specifications.As device information was not made available, device history record and complaint history review cannot be completed.According to clinical/medical investigation, patient underwent a right tha 9 months after sustaining a labral tear while at work.Approximately 4 months post primary rt tha, a revision was required due to loosening and continued pain.The provided medical records state that on post-op day 1, the patient fell to the floor while getting up from the toilet.An x-ray was taken following the fall, which reported no fracture or dislocation.The patient returned for his 3-month follow-up with continued pain and did not feel he was making any progress.The doctor indicated that an x-ray taken about 3 weeks post-op revealed the femoral component had subsided about 5 or 6 mm.The patient underwent a revision of the femoral component due to progressive subsidence and concern for loosening.Approximately 11 months after the revision, the patient was seen for a follow-up, with a complaint of tenderness of the greater trochanteric, and a greater trochanteric bursitis injection was recommended/requested.Four days later, the patient presented to the ed with a complaint of rt hip pain.He denied any particular trauma or injury, however he stated he is involved with a pro wrestling group and he ¿had to get down on the ground a couple days ago onto his knees.¿ a ct was performed which revealed periprosthetic lucency measuring up to 4mm medially and 4mm laterally, which appeared new since the radiograph from on (b)(6) 2017.Also noted was a thin linear lucency extending from the lateral cortex of the greater trochanter to the prosthesis, concerning for non-displaced fracture.The patient was instructed to use crutches, with no weight bearing on right leg.He received a trochanteric bursitis injection 6 weeks later.No additional records are provided, and the explanted device has not been returned for analysis.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore, no medical assessment can be performed at this time.The potential probable causes for this event could include but not limited to a user or procedural error.Based on this investigation, the need for corrective action is not indicated.A review of risk management files and the instructions for use found that the probable cause failures were documented appropriately.The potential probable causes for this event could include but not limited to a patient condition, user or procedural error.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

Event Description

It was reported that after an initial right tha on may 5, 2017 due to a labral tear, plaintiff underwent right revision surgery on may 16, 2017 due to femoral loosening.Following revision surgery, plaintiff continues to have chronic pain syndrome and underwent a trochanteric injection procedure on may 31, 2018.No medical records have been received indicating a second revision surgery or additional interventions.Plaintiff continues with chronic pain syndrome managed with medication and physiotherapy.

Manufacturer Narrative

The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the revision was performed due to subsidence and loosening of the femoral stem.The patient¿s post-operative fall cannot be excluded as a contributing factor to the subsidence and loosening.Additionally, patient¿s complaint of continued pain and the concern for a non-displaced fracture can also be attributed to the patient¿s ¿pro wrestling¿ involvement, and/or multiple co-morbidities.The patient impact beyond the revision and reported continued pain cannot be determined.However, it was reported the patient¿s pain was being managed with medical marijuana.No further clinical assessment is warranted at this time.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 revealed similar events for the listed device over the previous 24 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the instructions for use for this device that implant loosening or fracture, particularly of smaller sized or high offset implants, is more likely to occur in patients who are young, physically active, and /or heavy, which may lead to implant failure and revision surgery.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.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing issue, lack of ingrowth, lifetime of device, traumatic injury or patient medical history.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.

• Brand Name: R3 3 HOLE ACET SHELL 54MM
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• 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 ; 1450 brooks road; memphis, TN 38116 ; 5123913905
• MDR Report Key: 11548661
• MDR Text Key: 241673087
• Report Number: 1020279-2021-02314
• Device Sequence Number: 1
• Product Code: JDH
• UDI-Device Identifier: 03596010598257
• UDI-Public: 03596010598257
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71335554
• Device Catalogue Number: 71335554
• Device Lot Number: 16LW11585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2016
• 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: 71335754 R3 20 DEG XLPE ACET LNR 36MM X 54MM; 71343603 OXINIUM FEM HD 12/14 36 MM -3; 71354705 REDAPT SLVLS MONO STEM 240MM SZ 16 SO
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 54 YR
• Patient Sex: Male