MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 22MM X MM40; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 71334940

Device Problems Material Discolored (1170); Material Deformation (2976); Scratched Material (3020); Unexpected Color (4055)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, an oxinium fem hd 12/14 22 mm +0 and an 20 deg xlpe acet lnr 22mm x mm40 are damaged.According to the pictures attached, both devices seemed to be used, present scratches, the oxinium fem hd 12/14 22 mm +0 is discolored and the 20 deg xlpe acet lnr 22mm x mm40 is deformed.These problems were detected during procedure, and patient injury was reported.The procedure was completed without delay using a smith and nephew back-up device.

Manufacturer Narrative

Internal complaint reference number: (b)(4) event description corrected.

Event Description

It was reported that, a patient returned complaining of noise in the hip following primary hip surgery with an r3 20 deg xlpe acetabular liner 22mm x mm 40 in 2019.Therefore, a hip revision surgery was performed on 02/02/2021, in order to replace the acetabular liner.Surgeon took x-rays which showed that the device presents scratches and is deformed.The revision surgery was completed without delay using a smith and nephew back-up device.

Manufacturer Narrative

Event description and explanted date added.Internal complaint reference number: (b)(4).

Event Description

It was reported that, a patient returned complaining of noise in the hip following primary hip surgery with an oxinium fem hd (b)(6) 22 mm +0 in 2019.Therefore, a hip revision surgery was performed on (b)(6) 2021, in order to replace the and oxinium head.Surgeon took x-rays and it showed that the device presents scratches, and is discolored.The revision surgery was completed without delay using a smith and nephew back-up device.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.The visual inspection report concluded that there are signs of polyethene damage on the periphery of the liner near the locking features.The damage seen on the polyethene liner could have resulted from the neck of the stem contacting the liner or during extraction of the liner.The clinical/medical evaluation concluded that based on the images and information provided, the reported ¿noise¿ likely resulted from the femoral head articulating directly on the acetabular shell secondary to liner disassociation, although the clinical root cause of the reported revision could not be definitively concluded.Component deformation/early wear may be seen with liner disengagement and/or excessive wear such as when 3rd body particulate remains in the joint.Per the lab retrieval analysis, the root cause of the damage could not be definitively concluded.The patient impact assessment is limited to the reported noise, explanted component findings (wear/deformation), and revision procedure.No further medical assessment could be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Possible causes could include but not limited to traumatic injury, surgical technique or size of device.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.

• Brand Name: R3 20 DEG XLPE ACET LNR 22MM X MM40
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11402709
• MDR Text Key: 234392134
• Report Number: 1020279-2021-01754
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010598066
• UDI-Public: 03596010598066
• Combination Product (y/n): N
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/15/2021

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: 08/04/2023
• Device Model Number: 71334940
• Device Catalogue Number: 71334940
• Device Lot Number: 13HM03877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 03/07/2021; 03/07/2021; 08/12/2021
• Supplement Dates FDA Received: 03/11/2021; 03/11/2021; 08/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention