• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITH & NEPHEW ORTHOPAEDICS LTD R3 44MM ID INTL COCR LINER 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key12532641
MDR Text Key273329343
Report Number3005975929-2021-00436
Device Sequence Number1
Product Code MRA
UDI-Device Identifier03596010596123
UDI-Public3596010596123
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P150030
Number of Events Reported1
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 Date03/29/2018
Device Catalogue Number71335856
Device Lot Number08CW15970
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/03/2021
Initial Date FDA Received09/27/2021
Supplement Dates Manufacturer Received11/05/2021
Supplement Dates FDA Received11/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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 SexMale
-
-