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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH 4.5MM PERIPHERAL SCREW - 32MM; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

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STRYKER GMBH 4.5MM PERIPHERAL SCREW - 32MM; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS. Back to Search Results
Catalog Number 5572-4532
Device Problem Device Slipped (1584)
Patient Problems Fall (1848); Pain (1994)
Event Date 08/08/2018
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
It was reported that patient's right shoulder was revised after patient suffered several falls and complained of pain.The glenoid baseplate was found to have loosened.Surgeon decided to use bone allograft in the glenoid and a humeral head on the existing stem.
 
Manufacturer Narrative
Investigation revealed the subject product to be a concomitant item.The device did not contribute to the reported event.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
 
Event Description
It was reported that patient's right shoulder was revised after patient suffered several falls and complained of pain.The glenoid baseplate was found to have loosened.Surgeon decided to use bone allograft in the glenoid and a humeral head on the existing stem.
 
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Brand Name
4.5MM PERIPHERAL SCREW - 32MM
Type of Device
SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key7848587
MDR Text Key119324063
Report Number0008031020-2018-00581
Device Sequence Number1
Product Code KWS
UDI-Device Identifier07613327098754
UDI-Public07613327098754
Combination Product (y/n)N
PMA/PMN Number
K130895
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue Number5572-4532
Device Lot Number4658ND
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 08/08/2018
Initial Date FDA Received09/05/2018
Supplement Dates Manufacturer Received08/30/2018
Supplement Dates FDA Received09/25/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
Patient Weight118
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