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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP ANCHORING PEG (2 EACH) PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

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SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP ANCHORING PEG (2 EACH) PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED Back to Search Results
Model Number 75017231
Device Problems Fitting Problem (2183); Mechanical Jam (2983); Positioning Problem (3009); Physical Resistance/Sticking (4012)
Patient Problem Failure of Implant (1924)
Event Date 06/11/2021
Event Type  Injury  
Event Description
It was reported that a revision of a 40mm pinnacle cup and exeter stem was performed due to instability. A 45 mm polar cup with screws and flanges was chosen. After trialing, it was decided pegs were necessary. First peg hole was removed uneventfully but the second became stuck after initially turning. Attempts to keep removing rounded the hex in cover. Eventually, hole cover was removed using midas rex causing a delay of 30 minutes or more. Cup was implanted, peg holes drilled and pegs impacted. Unfortunately the pegs didn¿t impact all the way in and were left proud. It was decided this was an unacceptable risk to the poly and cup was removed. Surgery was finished using a competitor's device. No patient harm reported.
 
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Brand NamePOLARCUP ANCHORING PEG (2 EACH)
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 Key12068003
MDR Text Key260959955
Report Number9613369-2021-00312
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K070278
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number75017231
Device Catalogue Number75017231
Device Lot NumberB2011161
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/25/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/25/2021 Patient Sequence Number: 1
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