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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. SL-PLUS FAMILY STEM (UNKN. SUB-FAMILY); PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

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SMITH & NEPHEW ORTHOPAEDICS AG UNKN. SL-PLUS FAMILY STEM (UNKN. SUB-FAMILY); PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED Back to Search Results
Catalog Number UNKN1102901
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bone Fracture(s) (1870)
Event Date 01/18/2021
Event Type  Injury  
Event Description
On the literature article named "ceramic-on-ceramic vs ceramic-on-polyethylene, a comparative study with 10-year follow-up", it was reported that after a sl-plus family stem had been implanted on 1 patient, intraoperative trochanteric fracture occurred in the one patient from the cope group.The event was treated using a trochanteric wire.The patient outcome is unknown.
 
Manufacturer Narrative
H3, h6: the study of van loon et.Al.[1] reports a 10-year study regarding the wear of ceramic-on-ceramic (coe) and ceramic-on-polyethylene (cope) hip pairings.17 cope and 25 coe cases were available for a follow-up.As this is a literature complaint, the parts, used in treatment, were not returned for investigation.It is reported that on 1 patient, intraoperative trochanteric fracture occurred.The event was treated using a trochanteric wire.The part and the batch number of this device are not known.Therefore, it is not possible to investigate whether the reported device met manufacturing specification upon release for distribution.A complaint history review was conducted.The reported failure is stated as a side effect in the ifu.The severity and the failure mode are covered through our risk management.As no device was received for investigation, a visual inspection could not be performed.No patient information nor any other medical documentation was provided, therefore, a thorough medical investigation could not be performed.Based on our investigations the failure mode and the relationship between the device and the reported event cannot be confirmed.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.To date, no further actions will be taken.Should additional information become available, this complaint will be reassessed.Smith and nephew will monitor the devices for further similar issues.(1): (b)(6).
 
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Brand Name
UNKN. SL-PLUS FAMILY STEM (UNKN. SUB-FAMILY)
Type of Device
PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS AG
schachenallee 29
aarau CH-50 00
SZ  CH-5000
MDR Report Key11988895
MDR Text Key255918754
Report Number9613369-2021-00284
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Type of Report Initial,Followup
Report Date 07/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKN1102901
Was Device Available for Evaluation? No
Date Manufacturer Received07/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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