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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 38MM ID INTL COCR LINER 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS LTD R3 38MM ID INTL COCR LINER 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number 71335850
Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)
Patient Problems Pain (1994); Toxicity (2333); Injury (2348)
Event Type  Injury  
Event Description
In (b)(6) 2015 right hip revision surgery was performed due to indications of device failure including elevated cobalt levels.
 
Manufacturer Narrative
It was reported that a right hip revision surgery was performed.During the revision, the hemi head, modular sleeve and r3 liner were removed.The r3 shell, stem, cone spout slot, head screw 20mm & head screw 15mm remained.As of today, device return and additional information has been requested for this complaint but has not become available.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.The available medical documents were reviewed.On (b)(6) 2015, the patient started having mild, anterior hip pain after getting hit from behind by a bus, this could have contributed towards the metal on metal failure and elevated cobalt levels.The intraoperative findings of discoloration and the reported pain and elevated cobalt levels are consistent with findings associated with metal debris.Without the supporting imaging or the analysis of the explanted components, the root cause of the reported symptoms noted in the legal claim cannot be confirmed.All the released devices involved met manufacturing specifications at the time of production.Further, it cannot be concluded that the reported events were associated with a mal-performance of the implant.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
Serious injury.
 
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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 CV31 3HL
UK  CV31 3HL
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK   CV31 3HL
Manufacturer Contact
sarah freestone
MDR Report Key7618079
MDR Text Key111634906
Report Number3005975929-2018-00225
Device Sequence Number1
Product Code NXT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup
Report Date 05/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/28/2019
Device Catalogue Number71335850
Device Lot Number09BW22126
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/06/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2009
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ACET SHELL 50MM 71335550/09FM18110; ACETABULAR SHELL, PART AND LOT # UNKNOWN; EMP 13 STEM 71291301/09JM16788; EMP13 SPOUT 71291664/09BAB0043A; FEMORAL STEM, PART AND LOT # UNKNOWN; HEMI HEAD 38MM 74122538/08EW17145; HEMI HEAD, PART AND LOT # UNKNOWN; MODULAR SLEEV 74222200/08JW19034; MODULAR SLEEVE, PART AND LOT # UNKNOWN; SCREW 15MM 71332515/02MM02054; SCREW 20MM 71332520/08JT23661; ACETABULAR SHELL, PART AND LOT # UNKNOWN; FEMORAL STEM, PART AND LOT # UNKNOWN; HEMI HEAD, PART AND LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age39 YR
Patient SexMale
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