MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 CONSTRAINED ACETABULAR LINER 54MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	71339154
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Arthralgia (2355)
Date of Event	11/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that, after a thr performed on (b)(6) 2021, the patient felt her hip "stuck" after standing up from a chair.X-rays and ct confirmed metal ring dislocation from the constrained liner.The ring is currently hanging around the neck of stem.Patient is fully weight bearing unaided but complaining of pain and fear that her hip may "stick" again.Patient is a high risk of dislocation due to medical conditions and a constrained liner is required.A subsequent surgery to remove the ring and replace the liner is being considered, but has not been scheduled yet.
Additional Manufacturer Narrative
H3, h6: although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the constrained liner.Given the nature of the alleged incident, the device could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the provided x-ray and computed tomography were reviewed and confirm the reported, as the metal ring can be seen hanging around the neck of the femoral stem and the femoral head does not appear to be centered within the acetabular cup but cannot confirm the head position with the available images.The reported ¿stuck¿ feeling of the hip and pain may be consistent with the mal position of the locking ring.A clinical root cause of the mal position of the locking ring cannot be confirmed whether related to technique or possible impingement and related to the patients anatomy however, it is noted the ¿patient is a high risk of dislocation due to medical conditions¿ and as such, this cannot be ruled out as a possible contributing factor.The r3 surgical technique warnings and precautions include ¿constrained liners should only be used as a last resort, and only when all other available options to avoid dislocations have been exhausted.Such options include, but are not limited to, reorienting or using a different liner option, using a prosthesis with a larger head diameter, a stem with increased offset, or a head with increased length.¿ the patient is noted to be fully weight bearing, unaided; but complaining of pain and fear that the hip may stick again, and a revision is being considered.We cannot make conclusions or assumptions on the future impact to the patient as the medical and surgical plan has not been determined and provided, to date.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 r3 constrained liner acetabular system revealed in the possible adverse effects that dislocation or fracture of the reinforcement ring may increase the risk for device dislocation.Periodic x-rays are recommended for close comparison with immediate postoperative conditions to detect evidence of ring disassociation or fracture.With evidence of ring disassociation or fracture, patients should be closely observed, the possibilities of further deterioration evaluated and the benefits of early revision considered.In addition, the patient should be advised that ring disassociation or fracture may require additional surgery.Besides, the warnings and precautions section revealed that the patient should be warned of surgical risks, and made aware of possible adverse effects including the risk of ring failure, device dislocations and component fracture.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 specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal loading of limb, alignment, patient anatomy and/or conditions, procedural/user error and/or 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: R3 CONSTRAINED ACETABULAR LINER 54MM
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• 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: 18223222
• Report Number: 1020279-2023-02342
• Device Sequence Number: 14853510
• Product Code: KWZ
• UDI-Device Identifier: 00885556020227
• UDI-Public: 00885556020227
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/08/2022
• Device Catalogue Number: 71339154
• Device Lot Number: 12JM04610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OX FM HD12/14 22MM+0(PN:71342200,LN:20LM17323).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female