MAUDE Adverse Event Report: STRYKER GMBH LATERAL ASSEMBLY, RADIAL HEAD IMPLANT, SIZE 2; ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS

Catalog Number	3100008
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed, any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that patient's radius was revised due to the head disassociating from the stem.
Additional Manufacturer Narrative
The reported event that lateral assembly, radial head implant, size 2 was alleged of 'component loosened' 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 as well as the affected device 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.Device was not returned.
Event or Problem Description
It was reported that patient's radius was revised due to the head disassociating from the stem.

• Brand Name: LATERAL ASSEMBLY, RADIAL HEAD IMPLANT, SIZE 2
• 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: 7546118
• Report Number: 0008031020-2018-00404
• Device Sequence Number: 1305383
• Product Code: KWI
• UDI-Device Identifier: 00886385022758
• UDI-Public: 00886385022758
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K070236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2018

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: 11/30/2020
• Device Catalogue Number: 3100008
• Device Lot Number: 24983401
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 05/25/2018
• Supplement Report FDA Received Date: 08/23/2018
• 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: Required Intervention
• Patient Age: 65 YR