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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG PLUS SL MIA DBL OFFSET ADAPT. RT 60/25MM PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

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SMITH & NEPHEW ORTHOPAEDICS AG PLUS SL MIA DBL OFFSET ADAPT. RT 60/25MM PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED Back to Search Results
Model Number 75004613
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2021
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference case (b)(4).
 
Event Description
It was reported that, during total hip replacement, a plus sl-plus mia dbl offset adapt. Right 60/25mm broke on impaction, inside the patient. All parts were retrieved by hand. Surgery was resumed, without any delay, with a smith & nephew back-up device. Patient was not injured as consequence of this problem.
 
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Brand NamePLUS SL MIA DBL OFFSET ADAPT. RT 60/25MM
Type of DevicePROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS AG
schachenallee 29
aarau CH-50 00
SZ CH-5000
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS AG
schachenallee 29
aarau CH-50 00
SZ CH-5000
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key13054835
MDR Text Key282729303
Report Number9613369-2021-00425
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123598
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number75004613
Device Catalogue Number75004613
Device Lot NumberB51295
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/08/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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