MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 METAL LINER IMPL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number UNKN01100907

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Injury (2348); No Information (3190); Metal Related Pathology (4530)

Event Date 05/18/2015

Event Type  Injury  

Event Description

[study: (b)(6); subject id: (b)(6); ae#: unk] it was reported that, after a right tha surgery had been performed, the clinical subject experienced an unspecified adverse event that was resolved by performing a revision surgery.An unspecified anthology size 5 stem, an unspecified size 46 metal femoral head, an unspecified size 46/54 chrome liner and an unspecified midland medical uncemented size 54 acetabular shell were explanted.The patient outcome is unknown.

Manufacturer Narrative

Smith & nephew, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based upon information which smith & nephew, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, inc., or its employees, that the report constitutes an admission that the device, smith & nephew, inc., or its employees caused or contributed to the potential event described in this report.

Event Description

It was reported that, after a right tha surgery had been performed, the clinical subject experienced an unspecified adverse event that was resolved by performing a revision surgery.An unspecified anthology size 5 stem, an unspecified size 46 metal femoral head, an unspecified size 46/54 chrome liner and an unspecified midland medical uncemented size 54 acetabular shell were explanted.The patient outcome is unknown.

Manufacturer Narrative

On (b)(6) 2021 we received additional information from the healthcare/investigation site that has triggered this supplemental report.Please be aware that the correct manufacturer number for the explanted r3 acetabular liner is 3005975929, and not 1020279.The manufacturer has already reported to the fda the explantation of the acetabular shell (1020279-2020-01920), the acetabular liner (1020279-2020-01921), and the modular head/sleeve (1020279-2020-01922).

Event Description

[study: anthology r11006-1; subject id: whh004; ae#: 1] it was reported that, after a r3-tha construct had been implanted on the right hip, the clinical subject experienced elevated metal ions.This adverse event was addressed by performing a revision surgery to remove the acetabular component, rendering a full conversion to tha.The anthology size 5 stem was left in-situ.This complaint is against the metallic liner.The patient outcome is unknown.

Manufacturer Narrative

As of today, device return and additional information has been requested for this complaint but has not become available.Since part details were not received for investigation no thorough manufacturing record review and assessment of the reported event can be performed.Smith and nephew has not received the device/adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient¿s particular case, our investigation remains inconclusive.No preventive or corrective action has been initiated as a result of this investigation.

Manufacturer Narrative

It was reported that a right hip revision surgery was performed; the acetabular component was explanted, the stem remained implanted.As of today, device return and additional information has been requested for this complaint but has not become available.Since part details were not received for investigation no thorough manufacturing record review and assessment of the reported event can be performed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The available medical documents were reviewed.Per complaint details, the patient required a second revision due to elevated metal ions which included conversion of the right bhr-tha construct to a full right tha/removal of the acetabular component approximately 6 years post 1st revision.Reportedly, the anthology stem size 5 remained in-situ; however, the site was ¿unable to provide data so far¿ regarding the acetabular component.Without the requested medical documentation, the clinical root cause of the reported event could not be fully assessed or concluded.The patient impact beyond the reported elevated metal ions and subsequent revision could not be determined.Without the return of the actual product involved or product information, our investigation could not proceed and remains inconclusive.Due to the insufficient information provided, a definitive root cause cannot be determined, and we are unable to determine specific factors known to contribute to the alleged fault.Should the device or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.No further investigation is warranted for this complaint.

• Brand Name: R3 METAL LINER IMPL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa warwickshire TN CV31 3HJ; UK CV31 3HJ
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, warwickshire TN CV31 3HJ; UK CV31 3HJ
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10103811
• MDR Text Key: 193286304
• Report Number: 1020279-2020-01921
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01100907
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female