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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN REFLECTION IMPL; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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SMITH & NEPHEW, INC. UNKN REFLECTION IMPL; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL Back to Search Results
Catalog Number UNKN01100401
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/17/2021
Event Type  Injury  
Event Description
It was reported that on literature review synergy cementless stem system in the article short-term clinical outcome comparison between bikini incision with anterior approach and orthopädische chirurgie münchen approach in total hip arthroplasty.One patient had a revision surgery due to intraoperative fracture while using unkn reflection metal cup impl.
 
Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting.The information states that the product logged under (b)(4) is a concomitant product.This concomitant product was already reported under (b)(4) (report number: 1020279-2021-02943).Therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report will be submitted.
 
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Brand Name
UNKN REFLECTION IMPL
Type of Device
PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key11648897
MDR Text Key244886710
Report Number1020279-2021-02946
Device Sequence Number1
Product Code JDH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKN01100401
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
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