UNKNOWN MOOVIS CUP (PRESS-FIT OR SCREWED) UNK_SEL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-08-23 for UNKNOWN MOOVIS CUP (PRESS-FIT OR SCREWED) UNK_SEL manufactured by Stryker Gmbh.

Event Text Entries

[156268677] This complaint has been reported during a literature review performed by the post market surveillance group. No product identification is possible. Based on the investigation results, no definitive relation could be established between the product and the reported failure adverse consequence. The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information will be provided. If further relevant information becomes available, the investigation will be reevaluated and resubmitted accordingly. Device disposition is unknown.
Patient Sequence No: 1, Text Type: N, H10


[156268678] The manufacturer became aware of a post-market clinical follow-up (pmcf) from (b)(6). The title of this report is? Prospective and a retrospective evaluation of the mid- to long-term outcomes of subjects treated with the moovistm prosthesis? Which is associated with the stryker moovis prosthesis. Within that publication, post- operative complications/ adverse events were reported which occurred between 2013 and 2016. It was not possible to ascertain specific device catalog or patient information from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 9 complaints were initiated retrospectively for different adverse events mentioned in the report. This product inquiry addresses neurodystrophy. 2 out of 4 cases. The pmcf report states,? 4 patients were diagnosed with neurodystrophy in post op, exhibiting moderate forms of this chronic pain syndrome. All the involved patients recovered from this neurodystrophty without significant sequelae.?
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0008031020-2019-01141
MDR Report Key8925860
Report SourceHEALTH PROFESSIONAL
Date Received2019-08-23
Date of Report2019-08-23
Date of Event2013-01-01
Date Mfgr Received2019-08-01
Date Added to Maude2019-08-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. ANNA JUSINSKI
Manufacturer Street325 CORPORATE DRIVE
Manufacturer CityMAHWAH NJ 07430
Manufacturer CountryUS
Manufacturer Postal07430
Manufacturer Phone2018315000
Manufacturer G1STRYKER GMBH
Manufacturer StreetBOHNACKERWEG 1 POSTFACH
Manufacturer CitySELZACH 2545
Manufacturer CountryCH
Manufacturer Postal Code2545
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN MOOVIS CUP (PRESS-FIT OR SCREWED)
Generic NameIMPLANT
Product CodeKYJ
Date Received2019-08-23
Catalog NumberUNK_SEL
Lot NumberUNKNOWN
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER GMBH
Manufacturer AddressBOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-08-23

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