MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number 71335558

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Unequal Limb Length (4534)

Event Date 11/29/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that, a right primary surgery was performed on (b)(6) 2010, during which a r3-tha system was implanted.The patient experienced chronic pain, limited range of motion and leg length discrepancy.Therefore, a revision was performed on (b)(6) 2023.During surgery implant loosening, femoral neck stress reaction due to impingement, impingement lesion due to capsule placement, and also synovitis and osteophytes were found.The system was exchanged for competitor implants.The patient was taken to the recovery room in stable condition.No other complications have been reported.

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, all documents provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.The reported pain is consistent with the intraoperative finding of impingement with a large impingement lesion.The noted cup placement, and impingement can lead to the loosening, the impingement lesion at the neck, and the leg length discrepancy.Therefore, a procedural variance cannot be ruled out.It cannot be concluded the impingement and subsequent revision was associated with a mal performance of the implant.The patient impact is the reported revision and post operative convalescence period.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the screw and liner, 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 devices.For the shell and the head, a review of complaint history revealed similar events for the listed device over the previous 12 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 instructions for use documents for total hip systems revealed that implant loosening has been identified in adverse events in primary and revision surgery section, it is more likely to occur in patients who are young, physically active, and/or heavy.Besides, it reveals in the postoperative warnings and precautions section that the patient should be advised to report any pain, decrease in range of motion, swelling, fever, squeaking, clicking, popping, grating, or grinding noises, and unusual incidences.Also, in the potential complications associated with total hip arthroplasty surgery, primary, or revision section that the leg length discrepancy can generate aggravated problems of the affected limb or contralateral extremity.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.For the shell, screw and liner, a historical review concluded that there are no prior actions related to this products and event.For the head, a previous action was initiated to update the instructions for use (ifu) for the birmingham¿ hip resurfacing (bhr¿) system.The revisions to the ifu include an expansion of the warnings for certain population subgroups.Besides, a field action was performed to remove sizes of femoral heads =46mm and corresponding bhr cups from the market due to observed revision rates which are higher than established benchmarks.Additionally, new information suggests that certain patient groups may also be at increased risk of early revision.It was confirmed that the listed batch was manufactured before corrective action implementation.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal motion over time and/or traumatic injury.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.Additional information: d4 (expiration date), h4 corrected data: d5, e1 (initial reporter name and address), h6 (health effect - clinical code).

• Brand Name: R3 3 HOLE ACET SHELL 58MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• 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: 18669547
• MDR Text Key: 334913317
• Report Number: 1020279-2024-00310
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 03596010598264
• UDI-Public: 03596010598264
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 03/06/2024

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 Expiration Date: 02/17/2019
• Device Catalogue Number: 71335558
• Device Lot Number: 09BM15520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: 03/05/2024
• Supplement Dates FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/19/2009
• 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: 71336525 / LOT#09DM03577; 71341156 / LOT#09AW21617; 74123144 / LOT#08DW16600
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female