MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN R3 SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number UNKNOWN

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

Patient Problems Infiltration into Tissue (1931); Injury (2348); No Information (3190); Metal Related Pathology (4530)

Event Date 05/18/2015

Event Type  Injury  

Event Description

[study: anthology r11006-1; 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.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 unknown r3 acetabular shell.The patient outcome is unknown.

Manufacturer Narrative

G3, h2, h3, and h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical evaluation concluded that 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 (ae#1) 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 ae(#1).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.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.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 damaged product, implant corrosion, or metal-on-metal contact.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, 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

[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 the patient outcome is unknown.

• Brand Name: UNKN R3 SHELL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis, tn TN 38116
• MDR Report Key: 10103809
• MDR Text Key: 193313726
• Report Number: 1020279-2020-01920
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• 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: 09/07/2021

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIRMINGHAM HIP MODULAR HEAD (BHMH) SLEEVE/UNK
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR