MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 38MM ID INTL COCR LINER 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71335850

Device Problem Biocompatibility (2886)

Patient Problems Cyst(s) (1800); Metal Related Pathology (4530)

Event Date 10/31/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference:(b)(4).

Event Description

It was reported that, after an r3-tha construct had been implanted on the left hip joint performed on (b)(6) 2010, the patient felt slight discomfort, without pain in the groin.During orthopedic consultation, a cyst of the anterior hip area was found, 45 ml of rusty fluid was evacuated and examined where the norms of chromium and cobalt were exceeded.At the end of (b)(6) 2021, metallosis was diagnosed and patient requires a revision surgery that has not been conducted yet.Patient's outcome is unknown.

Manufacturer Narrative

It was reported that, after an r3-tha construct had been implanted on the left hip joint performed on (b)(6) 2010, at the end of (b)(6) 2021, metallosis was diagnosed and patient requires a revision surgery that has not been conducted yet.Additional information has been requested for this complaint but has not become available.A review of the historical complaints data for the modular head, sleeve and r3 liner was performed using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.No other similar complaints were identified to involve this batch for the modular head and the r3 liner.Other similar complaints were identified to involve this batch for the sleeve.However, as the device is no longer sold, no action is to be taken.No other similar complaints have been identified for the part number and the reported failure mode.In the absence of the actual devices, 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.Modular heads, sleeves and r3 liners have been phased out from the market and as a result there is no live risk management file to review.Therefore, an evaluation of failure modes is not required.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; it was confirmed that the listed batch was manufactured before corrective action implementation.No further escalation actions required.Based on the reported symptoms it cannot be concluded that the events/clinical reactions (discomfort, and cyst of the anterior hip area that contained 45 ml of rusty fluid and elevated cobalt, chromium) were associated with a mal performance of the implant.The patient impact cannot be determined at this time.Based on the available information we cannot further investigate or confirm the reported complaint, or the details supplied in this complaint.The investigation remains inconclusive, and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.If additional information becomes available in the future, this case will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: R3 38MM ID INTL COCR LINER 50MM
• 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: 13451820
• MDR Text Key: 285349934
• Report Number: 3005975929-2022-00036
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010596093
• UDI-Public: 3596010596093
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 71335850
• Device Lot Number: 08GW18012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2022
• Date Device Manufactured: 07/31/2008
• 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
• Patient Age: 54 YR
• Patient Sex: Female