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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH RHEAD STEM IMPLANT PLASMA COATED, SIZE 2; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
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STRYKER GMBH RHEAD STEM IMPLANT PLASMA COATED, SIZE 2; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER Back to Search Results
Catalog Number 3102011
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Pain (1994)
Event Date 02/27/2019
Event Type  Injury  
Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device evaluated by mfr: implanted in patient.
 
Event Description
It was reported that the patient complained of pain of the left radius after implantation in (b)(6) 2017.A ct scan on (b)(6) 2019 showed loosening of the radial head.Possible cause or contributor for loosening was not reported to the rep.Surgeon has not yet reported any plan to revise the patient.Per the operative report, as part of the ct scan, soft tissues appeared within normal limits and the remaining bony structures were unremarkable, therefore no serious injury occurred.
 
Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event such as the various x-rays, the patient activity level as well as the affected device must be available in order to determine the root cause of the complaint event.In the complaint detail, the surgeon inquired if the rhead prosthesis was subjected to a recall.The stryker rhead was recalled voluntarily in october 2017.Healthcare professionals are advised to continue to follow up with their patients who are using the stryker rhead radial implant system in accordance with the routine standard of care.The instrument sets for explantation, in case it would be needed, are still available to the users.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
 
Event Description
It was reported that the patient complained of pain of the left radius after implantation in january 2017.A ct scan on (b)(6)2019 showed loosening of the radial head.Possible cause or contributor for loosening was not reported to the rep.Surgeon has not yet reported any plan to revise the patient.Per the operative report, as part of the ct scan, soft tissues appeared within normal limits and the remaining bony structures were unremarkable, therefore no serious injury occurred.
 
Event Description
It was reported that the patient complained of pain of the left radius after implantation in (b)(6)2017.A ct scan on (b)(6)2019 showed loosening of the radial head.Possible cause or contributor for loosening was not reported to the rep.Surgeon has not yet reported any plan to revise the patient.
 
Manufacturer Narrative
Correction: sections b1, b2, b5, h1.The reported event could be confirmed, since x-rays showing the loosening of the device were provided.More detailed information about the patient's data and patient's activity level is needed in order to determine the root cause of the complaint.However, based on the past complaint history a possible cause for the implant loosening is, but is not limited to the application of inappropriate loads on the device could be one of the most probable reasons of the loosening.As a reminder, the ifu clearly states: "warnings (see the patient counseling information section also) 1.Strenuous loading, excessive mobility, and articular instability all may lead to accelerated wear and eventual failure by loosening, fracture, or dislocation of the device." a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
 
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Brand Name
RHEAD STEM IMPLANT PLASMA COATED, SIZE 2
Type of Device
PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key8441696
MDR Text Key139695996
Report Number0008031020-2019-00297
Device Sequence Number1
Product Code KWI
UDI-Device Identifier00886385024028
UDI-Public00886385024028
Combination Product (y/n)N
PMA/PMN Number
K002644
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 09/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date12/31/2019
Device Catalogue Number3102011
Device Lot Number10181-L07
Was Device Available for Evaluation? No
Date Manufacturer Received08/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number8031020-10/24/2017-002-R
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age55 YR
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