MAUDE Adverse Event Report: STRYKER GMBH RADIO CAPITELLUM LARGE, RIGHT; PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Model Number	410-0002
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Injury (2348)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information in this report was provided by stryker legal affairs.No additional information is available at this time.Therefore, the exact cause of the reported event cannot be determined.Device not available.
Event or Problem Description
It's reported that the patient underwent a right stryker lateral assembly radial head and stem elbow implant implanted on (b)(6) 2011.After implantation, the patient began to experience pain, decreased function and instability of his right elbow.After images showed loosening of the components, the patient underwent revision surgery on (b)(6) 2019.
Event or Problem Description
It's reported that the patient underwent a right stryker lateral assembly radial head and stem elbow implant implanted on (b)(6) 2011.After implantation, the patient began to experience pain, decreased function and instability of his right elbow.After images showed loosening of the components, the patient underwent revision surgery on (b)(6)2019.
Additional Manufacturer Narrative
Correction: refer to a2, h6 patient code.The reported event that radio capitellum large, right was alleged of 'implant - instability' 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 x-rays, patient details, patient activity levels.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.

• Brand Name: RADIO CAPITELLUM LARGE, RIGHT
• Common Device Name: PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9960687
• Report Number: 0008031020-2020-01281
• Device Sequence Number: 11366747
• Product Code: JDB
• UDI-Device Identifier: 00886385025957
• UDI-Public: 00886385025957
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K070236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2020

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: 03/31/2017
• Device Model Number: 410-0002
• Device Catalogue Number: 4100002
• Device Lot Number: 36202001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 07/06/2020
• 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: 55 YR