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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN_SELZACH_PRODUCT; IMPLANT

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STRYKER GMBH UNKNOWN_SELZACH_PRODUCT; IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problem Device Slipped (1584)
Patient Problem Pain (1994)
Event Date 05/01/2015
Event Type  Injury  
Event Description
Total ankle revision due to talar component subsidence and pain.Bone removal and talar component was loose so replacement was cemented in with a larger poly.
 
Manufacturer Narrative
The reported device was manufactured and distributed by small bone innovation, inc., (b)(4) and implanted prior to howmedica osteonics corp.¿s purchase of certain assets of sbi on august 1, 2014.Stryker became legal manufacturer of this product on april 1, 2015 and has taken the responsibility for medical device reporting.Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Unknown star talar component.Device not returned.
 
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Brand Name
UNKNOWN_SELZACH_PRODUCT
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH   2545
Manufacturer Contact
rose haas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4900072
MDR Text Key6066599
Report Number0008031020-2015-00279
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 05/11/2015
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? Yes
Device Operator Lay User/Patient
Device Catalogue NumberUNK_SEL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/11/2015
Initial Date FDA Received07/08/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Age73 YR
Patient Weight79
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