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

Catalog Number 71335856

Device Problem Biocompatibility (2886)

Patient Problems Inflammation (1932); Osteolysis (2377); Fibrosis (3167); Metal Related Pathology (4530)

Event Date 03/27/2018

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

(b)(6) it was reported that after a r3 tha construct was implanted on (b)(6) 2010 the plaintiff experienced an aseptic lymphocyte-dominant vasculitis-associated lesion reaction (alval), elevated ion levels on blood, and pseudotumor on left hip.A revision surgery was performed on (b)(6) 2018 to treat these adverse events.During the revision surgery a brownish solid mass whose was solid, pasty, and brownish was found.Also, a peripheral osteolysis at the acetabular level and at the medial level on the calcar for the femur was noted.After the surgery, microscopic study of the solid mass revealed reactive fibrosis with amorphous substance, chronic inflammation and fibro histiocytic reaction associated with a black pigment and siderophages.The patient outcome is unknown.

Manufacturer Narrative

H3, h6: it was reported that left hip revision surgery was performed.During the revision the r3 liner and modular head were explanted.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, modular head, modular sleeve, r3 shell and stem 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, modular head, r3 shell, or stem.Similar complaints have been identified for the sleeve, 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 upon release for distribution.Review of manufacturing records did not reveal any waivers, concessions, manufacturing, or material abnormalities that could have contributed to this issue.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.No further actions are required at this time.The available medical documents were reviewed.Although it was reported the patient experienced an aseptic lymphocyte-dominant vasculitis-associated lesion reaction, the pathology report did not confirm.The reported elevated metal ions and intraoperative findings of pseudotumor, brown pasty tissue and osteolysis along with the pathological findings may be consistent with an adverse reaction to metal debris.However, the clinical root cause cannot be confirmed.It cannot be concluded that the reported clinical reactions were associated with a malperformance of the implant or implant failure.The patient impact beyond the revision and expected transient post-operative convalescence period cannot be determined.Without the return of the actual products involved or additional information, our investigation remains inconclusive, and a definitive root cause cannot be determined.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.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 44MM ID INTL COCR LINER 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: 12526314
• MDR Text Key: 273125768
• Report Number: 3005975929-2021-00430
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010596123
• UDI-Public: 3596010596123
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2018
• Device Catalogue Number: 71335856
• Device Lot Number: 08KW19581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/25/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2008
• 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): Hospitalization; Other
• Patient Age: 70 YR
• Patient Sex: Male