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

Catalog Number 71335856

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Metal Related Pathology (4530); Nodule (4551)

Event Date 07/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

(b)(6).It was reported that after a r3 tha construct was implanted on (b)(6) 2008 the plaintiff experienced elevated metal ion levels on blood and pseudotumor.A revision surgery was performed on (b)(6) 2019 to treat these adverse events.During the surgery, a huge amount of brownish-black fluid was found on the hip.Additionally, grayish-black tissue in a large portion of the hip was found, and a pseudotumor was removed around the acetabulum and femoral portion on the hip.Microscopy study of the tissue removed showed tissue necrosis, fibrosis, chronic inflammation, with a good foreign body histiocyte reaction.Patient outcome is unknown.

Manufacturer Narrative

G3, h2, h3, and h6: it was reported that left hip revision surgery was performed due to the pseudotumor formation and elevated metal ions levels in blood.The r3 shell, r3 liner, modular head, modular sleeve used in treatment were all explanted but were not returned for evaluation.Additional information has been requested for this complaint but has not become available.A review of the complaint history for the r3 liner, modular head, and modular sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Other similar complaints have been identified for the r3 liner, modular head, and sleeve.However, as the devices are no longer sold, no action is to be taken.On account of the fact devices reportedly involved in this incident were not returned for evaluation, the relevant production records were reviewed.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.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 aseptic lymphocyte-dominant vasculitis-associated lesions was suspected, the pathology report did not confirm.The elevated metal ion levels and intraoperative findings of blackish/brownish liquid, black gray caseous fabrics, and pseudotumor along with the synovial tissue fragments that show necrosis, fibrosis, chronic inflammation and histiocytic reaction to foreign body may be consistent with an adverse reaction to metal debris.However, based on the information provided, the clinical root cause of the clinical reactions cannot be confirmed.It cannot be concluded that the clinical reactions were associated with a malperformance of the implant.The patient impact beyond the revision cannot be determined.Without the return of the actual product involved or product information, our investigation could not proceed and remains inconclusive.A definitive root cause cannot be determined, and we are unable to determine 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.No further investigation is warranted for this complaint.H6: update codes.

• Brand Name: R3 44MM ID INTL COCR LINER 56MM
• 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; austin, TX 78735 ; 5123913905
• MDR Report Key: 12532641
• MDR Text Key: 273329343
• Report Number: 3005975929-2021-00436
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 03596010596123
• UDI-Public: 3596010596123
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P150030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2018
• Device Catalogue Number: 71335856
• Device Lot Number: 08CW15970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 09/27/2021
• Supplement Dates Manufacturer Received: 11/05/2021
• Supplement Dates FDA Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2008
• 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: MODULAR SLEEVE +4MM 12/14/07KW14071; SYN POR HO FEM COM SZ 18/ 02JM02565; MODULAR SLEEVE +4MM 12/14/07KW14071; SYN POR HO FEM COM SZ 18/ 02JM02565
• Patient Outcome(s): Required Intervention
• Patient Sex: Male