MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 42MM ID US COCR LNR 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL

Catalog Number 71341154

Device Problem Biocompatibility (2886)

Patient Problems Pain (1994); Synovitis (2094); Metal Related Pathology (4530)

Event Date 04/02/2021

Event Type  Injury  

Event Description

It was reported that, after an r3-tha construct had been implanted on the patient¿s right hip on (b)(6) 2009, the patient experienced metallosis and pain.This adverse event was treated with a revision surgery on (b)(6) 2021.During this procedure, all components were explanted and replaced with a competitors¿ tha system.Intraoperatively, inflammatory synovial changes were noticed with a small gross macroscopic area with tissue staining.The trunnion showed mild signs of corrosion.The patient was transferred in a stable condition to the recovery room.

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

H3, h6: it was reported that a right hip revision surgery was performed due to metallosis and pain.Intraoperatively, inflammatory synovial changes and trunnion mild signs of corrosion were noticed.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.A review of the historical complaints data for the metal liner was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints were identified for the metal liner, however, as the device is no longer sold, no action is to be taken.In the absence of the actual device, the production records were reviewed for the devices reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.Review of the product ifu 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 product 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.The clinical information provided, of tissue staining and corrosion on the trunnion may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure.Based on the available information we can confirm the reported complaint, however without further information 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 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.

• Brand Name: R3 42MM ID US COCR LNR 54MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL
• 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: 14467826
• MDR Text Key: 292349988
• Report Number: 3005975929-2022-00322
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 00885556022351
• UDI-Public: 885556022351
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/29/2018
• Device Catalogue Number: 71341154
• Device Lot Number: 08MW20435
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2022
• Date Device Manufactured: 12/31/2008
• 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): Other; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male