MAUDE Adverse Event Report: STRYKER GMBH LATERAL ASSEMBLY, RADIAL IMPLANT, SIZE 1; ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS

Catalog Number	3100000
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/06/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on updated information, complaint investigation has been re-assessed and conclusions remain unchanged.The reported event that a radial head implant did not work properly 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 precise 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 not available.
Event or Problem Description
A surgeon customer complained that a radial head implant did not work properly.Update 26-sept-2018: "it¿s alleged by the attorney, through the filing of a legal claim, that the patient had a stryker lateral head and stem elbow implanted on or about (b)(6) 2016.It is further alleged that after his elbow replacement, he began to experience increasing pain and decreased function.He then visited his orthopedic doctor who confirmed loosening of the radial head components and recommended immediate revision surgery, which took place on or about (b)(6) 2016.Within one week of his revision surgery, the claimant had to undergo re-revision of the radial head component on or about (b)(6) 2016 due to the component coming loose and dislodging for a second time." this pi is for revision of primary.

• Brand Name: LATERAL ASSEMBLY, RADIAL IMPLANT, SIZE 1
• 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: 7914645
• Report Number: 0008031020-2018-00657
• Device Sequence Number: 16560310
• Product Code: KWI
• UDI-Device Identifier: 00886385022673
• UDI-Public: 00886385022673
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K062898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/27/2018

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: 09/30/2020
• Device Catalogue Number: 3100000
• Device Lot Number: 24880201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 09/27/2018
• 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