MAUDE Adverse Event Report: STRYKER GMBH RHEAD STEM IMPLANT PLASMA COATED, SIZE 2; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Catalog Number	3102011
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/27/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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 or Problem 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.
Additional 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.

• Brand Name: RHEAD STEM IMPLANT PLASMA COATED, SIZE 2
• Common Device Name: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8441696
• Report Number: 0008031020-2019-00297
• Device Sequence Number: 3057556
• Product Code: KWI
• UDI-Device Identifier: 00886385024028
• UDI-Public: 00886385024028
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K002644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/06/2019

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 3102011
• Device Lot Number: 10181-L07
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 04/11/2019; 08/12/2019
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 05/06/2019; 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 8031020-10/24/2017-002-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR