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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH 6.5MM CENTER SCREW - 40M M; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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STRYKER GMBH 6.5MM CENTER SCREW - 40M M; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Back to Search Results
Catalog Number 5573-6540
Device Problems Osseointegration Problem (3003); Appropriate Term/Code Not Available (3191)
Patient Problems Osteolysis (2377); Inadequate Osseointegration (2646)
Event Date 10/12/2023
Event Type  Injury  
Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
 
Event Description
The surgeon scheduled a revision surgery with a stryker representative.During the surgery, it was found that the baseplate/screw/glenosphere construct was loose, with two of the four screws not contained within the construct.The glenoid baseplate/glenosphere/screws and the cup/poly construct were removed.A 40mm humeral head was attached to the existing humeral stem.The indication for the primary procedure was a fracture.The revision surgery was successful.
 
Event Description
The surgeon scheduled a revision surgery with a stryker representative.During the surgery, it was found that the baseplate/screw/glenosphere construct was loose, with two of the four screws not contained within the construct.The glenoid baseplate/glenosphere/screws and the cup/poly construct were removed.A 40mm humeral head was attached to the existing humeral stem.The indication for the primary procedure was a fracture.The revision surgery was successful.
 
Manufacturer Narrative
Please note the corrections made to the d1 product long description and g1 manufacturing site for devices: this device is concomitant and did not contribute to the reported failure.Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
 
Event Description
The surgeon scheduled a revision surgery with a stryker representative.During the surgery, it was found that the baseplate/screw/glenosphere construct was loose, with two of the four screws not contained within the construct.The glenoid baseplate/glenosphere/screws and the cup/poly construct were removed.A 40mm humeral head was attached to the existing humeral stem.The indication for the primary procedure was a fracture.The revision surgery was successful.
 
Manufacturer Narrative
Correction: h6 (results & conclusion codes).This device is concomitant and did not contribute to the reported failure.Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
 
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Brand Name
6.5MM CENTER SCREW - 40M M
Type of Device
PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ  2545
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key18096790
MDR Text Key327678331
Report Number0009610622-2023-00401
Device Sequence Number1
Product Code KWS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K202289
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 02/20/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue Number5573-6540
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/24/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age5 YR
Patient SexFemale
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