MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 71337648

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

Patient Problems Failure of Implant (1924); Loss of Range of Motion (2032); Discomfort (2330); Joint Contracture (4528)

Event Date 01/02/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

/-*us legal* it was reported that patient underwent medically-indicated revision of the r3 system left hip on (b)(6) 2019.The patient revision surgery was performed due to pops, hip friction, hip sticking, and reduced range of motion in her left hip joint.The patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the provided medical records were reviewed.However, they do not aid in the clinical investigation as they precede the reported events.Therefore, based on insufficient information, no further medical assessment cannot be performed at this time.Should any additional relevant clinical information be provided, this complaint would be re-assessed.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 could be alignment, fit/size of device used, wear or lifetime of device used.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.

Event Description

It was reported that patient underwent medically-indicated revision of the r3 system left hip on (b)(6) 2019.The patient revision surgery was performed due to pops, hip friction, hip sticking, and reduced range of motion in her left hip joint.The liner and femoral head were explanted during the procedure.The patient was transferred to the recovery room in good condition.

Manufacturer Narrative

Internal reference number: (b)(4).Internal 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 based on the information provided, the clinical root cause of the reported pops, hip friction and sticking, and reduced range of motion in her left hip joint is related to the shifted liner.However, it is unclear if the patient¿s awkward position while bending is a contributing factor to the liner¿s shift in position.The surgeon indicated the wear seen on the femoral head was secondary to its articulating at the level of the acetabulum.The impact to the patient beyond that which has already been reported cannot be determined.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 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 risk management file and instructions for use documents 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, excessive forces, abnormal loading, alignment or fit/size.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.Corrected data: e1 initial reporter name and address, g2.

• Brand Name: R3 20 DEG XLPE ACET LNR 32MM X 48MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 11384566
• MDR Text Key: 233727309
• Report Number: 1020279-2021-01612
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/15/2022

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 Catalogue Number: 71337648
• Device Lot Number: 17GM00246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 08/18/2021; 01/17/2022; 03/11/2022
• Supplement Dates FDA Received: 08/19/2021; 01/25/2022; 03/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: POLARSTEM STEM/75100463/B1610086; R3 3 HOLE ACET SHELL MM48/71335548/18GM16199
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 52 YR
• Patient Sex: Female