MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 40MM ID INTL COCR LINER 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71335852

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Toxicity (2333); Arthralgia (2355); Metal Related Pathology (4530)

Event Date 04/25/2018

Event Type  Injury  

Event Description

Can legal mdl.It was reported that a revision surgery was performed on the patients left hip due to pain and high metal ion levels.The patient outcome is unknown.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the modular head, r3 liner and modular sleeve were removed.The r3 shell and stem remained implanted.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the r3 liner and modular head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the r3 liner.Similar complaints have been identified for the modular head.However, as the device is no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.The available medical documents were reviewed.Although it was reported that the patient had elevated metal ion levels, neither the levels nor the lab reports were provided for review.Without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported pain, elevated metal ion levels and trunnionosis cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

Manufacturer Narrative

H10: additional information in a2, a3, b5, b6, e1 and h6 (medical device problem code).

Event Description

It was reported that, after an r3-tha construct had been implanted on (b)(6) 2011, the patient experienced pain and pain and had high metal ion levels.A revision surgery was performed on (b)(6) 2018: liner, head and sleeve were explanted, while the acetabular cup and the stem were left in-situ.

Manufacturer Narrative

H3, h6: it was reported that a left revision surgery was performed due to pain and high metal ion levels.The r3 metal liner, modular head and sleeve were explanted.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 r3 metal liner was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.No similar complaints were found for the device, 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 required.The available medical documents were reviewed.Without the supporting lab/pathology reports, imaging, and/or the analysis of the explanted components, the root cause of the reported pain, elevated cobalt levels and trunnionosis cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.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 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 40MM ID INTL COCR LINER 52MM
• 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: sarah freestone ; aurora house, spa park; leamington spa warwickshire CV31 -3HL ; UK CV31 3HL ; 0447940038
• MDR Report Key: 10176457
• MDR Text Key: 195901047
• Report Number: 3005975929-2020-00207
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010596109
• UDI-Public: 3596010596109
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2018
• Device Catalogue Number: 71335852
• Device Lot Number: 08AW15259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/22/2020
• Initial Date FDA Received: 06/19/2020
• Supplement Dates Manufacturer Received: 12/27/2020; 10/05/2022; 10/25/2022
• Supplement Dates FDA Received: 12/06/2020; 10/11/2022; 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2008
• 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
• Treatment: R3 3 HOLE ACET SHELL 52MM; R3 3 HOLE ACET SHELL 52MM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male