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

Model Number 410-0002

Device Problem Loss of Osseointegration (2408)

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Injury (2348)

Event Date 12/12/2019

Event Type  Injury  

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 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 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.

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
• Type of Device: PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9960687
• MDR Text Key: 191152370
• Report Number: 0008031020-2020-01281
• Device Sequence Number: 1
• Product Code: JDB
• UDI-Device Identifier: 00886385025957
• UDI-Public: 00886385025957
• Combination Product (y/n): N
• PMA/PMN Number: K070236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR