MAUDE Adverse Event Report: STRYKER GMBH RADIAL HEAD IMPLANT #2 (STERILE PACKED); ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS

Catalog Number	RHAH2
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device remains implanted.
Event or Problem Description
Due to the alert sent out by mhra doctor review the patient who had an rhead implanted two years ago the patient in question had primary surgery for a fracture, has not been revised, her activity level is medium.There is bone resorption around the head of the radial head implant but not around the implant stem.
Event or Problem Description
Due to the alert sent out by mhra doctor review the patient who had an rhead implanted two years ago the patient in question had primary surgery for a fracture, has not been revised, her activity level is medium.There is bone resorption around the head of the radial head implant but not around the implant stem.
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, operative reports, as well as the pre- and post- operative x-rays must be available in order to determine the root cause of the complaint event.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: RADIAL HEAD IMPLANT #2 (STERILE PACKED)
• Common Device Name: ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8457269
• Report Number: 0008031020-2019-00327
• Device Sequence Number: 13539387
• Product Code: KWI
• UDI-Device Identifier: 00886385024660
• UDI-Public: 00886385024660
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: RHAH2
• Device Lot Number: 25206501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR