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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN REFLECTION ALL-POLY CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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SMITH & NEPHEW, INC. UNKNOWN REFLECTION ALL-POLY CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number UNKNOWN
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Inadequate Osseointegration (2646)
Event Date 12/05/2013
Event Type  Injury  
Manufacturer Narrative
H10: internal complaint reference: case (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.Doi: https://doi.Org/10.1002/jbm.B.35023.Wolf, s., johannessen, a.C., ellison, p., furnes, o., hallan, g., rogg, k.,.& høl, p.J.(2022).Inflammatory tissue reactions around aseptically loose cemented hip prostheses: a retrieval study of the spectron ef stem with reflection all-poly acetabular cup.Journal of biomedical materials research part b: applied biomaterials, 110(7), 1624-1636.
 
Event Description
It was reported that on literature review "inflammatory tissue reactions around aseptically loose cemented hip prostheses: a retrieval study of the spectron ef stem with reflection all-poly acetabular cup" 114 months after a tha surgery, where an spectron ef stem and a reflection non-crosslinked all-polly cup were implanted, the patient underwent a revision surgery due to loosinng of the cup and the stem.The study determined that both the stem and the cup were worn, additionally pe, cr, co and zr particles were present in the periprosthetic tissue.Current health status of the patient is unknown.No further information is available.
 
Manufacturer Narrative
Internal complaint reference number: (b)(4).Section b1 was corrected.
 
Event Description
It was reported that on literature review "inflammatory tissue reactions around aseptically loose cemented hip prostheses: a retrieval study of the spectron ef stem with reflection all-poly acetabular cup" 114 months after a tha surgery, where an spectron ef stem and a reflection non-crosslinked all-polly cup were implanted, the patient underwent a revision surgery due to loosening of the cup and the stem.The study determined that both the stem and the cup were worn, additionally pe, cr, co and zr particles were present in the periprosthetic tissue.Also, the study determined that the polyethylene (pe) particles liberated by the cup's wear may have been the primary cause of the osteolysis in the femur, as well as the loosening of the stem.Current health status of the patient is unknown.No further information is available.The primary tha was performed on (b)(6) 2004 and the revision surgery was performed on (b)(6) 2013.
 
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Brand Name
UNKNOWN REFLECTION ALL-POLY CUP
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key18534388
MDR Text Key333120713
Report Number1020279-2024-00161
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Reporter Country CodeNO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Literature,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 04/24/2024
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 Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/16/2024
Initial Date FDA Received01/18/2024
Supplement Dates Manufacturer Received02/21/2024
03/27/2024
Supplement Dates FDA Received02/26/2024
04/24/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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
71302800 / LOT# UNKNOWN; 71312102 / LOT# UNKNOWN; UNKNOWN SPECTRON EF STEM
Patient Age74 YR
Patient SexMale
Patient Weight73 KG
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