MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 44MM ID US COCR LNR 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71341156

Device Problem Biocompatibility (2886)

Patient Problem Metal Related Pathology (4530)

Event Date 11/22/2022

Event Type  Injury  

Event Description

It was reported that, after a thr surgery, the patient had elevated cocr levels in blood.Revision surgery was performed, there was a removal of a cocr mod head and a r3 44mm id us cocr lnr 56mm, exchanged for or3o implants.Can't get taper sleeves and head apart.Patient current health status is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew 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, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.Case: (b)(4).

Manufacturer Narrative

It was reported that a revision surgery was performed due to elevated cobalt and chrome levels in blood.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.In the absence of a returned product, visual inspection was conducted on a photograph of the subject parts.The image provided showed the head with its sleeve attached, and the metal liner.The part and lot numbers of the head and sleeve are not visible.The part and lot numbers of the metal liner are visible, but the lot number is illegible.Multiple lot number variations were checked on sap, but none of those combinations exist.Therefore the lot number could not be confirmed and it was not possible to perform a complete complaint history review nor a device history review.Without a definitive lot number a complete complaint history review cannot be performed for the r3 liner.A review of historical complaints data was performed using the part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the r3 liner.Without definitive part/lot numbers a complaint history review cannot be performed for the modular head and sleeve.However, as the devices are no longer sold, no action is to be taken.As no device batch numbers were provided for investigation, manufacturing record review could not be performed.If more information is received, this investigation will be reopened.The review of the ifus found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.The available medical documents were reviewed.A single photo of the explants was provided and was reviewed.However, the photo alone does not contribute to the clinical/medical investigation of the clinical root cause of the reported elevated cocr levels in blood and "can't get the taper sleeve and head apart." as of the date of this medical investigation, the requested clinical documentation has not been provided for evaluation.Therefore, there were no clinical factors found which would have contributed to the reported event.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.Based on the information provided we cannot confirm or further investigate the reported complaint, our investigation remains inconclusive, and a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: R3 44MM ID US COCR LNR 56MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16009071
• MDR Text Key: 305746954
• Report Number: 3005975929-2022-00494
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71341156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2023
• 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
• Treatment: UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) SLEEVE.; UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH).
• Patient Outcome(s): Other