MAUDE Adverse Event Report: STRYKER GMBH RADIO CAPITELLUM, RECON HEAD, SIZE #2; PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Model Number 410-0007

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 reported device is part of a legal matter.If additional information becomes available, it will be provided in a supplemental report.Device not available; legal matter.

Event Description

It's reported by the attorney, through the filing of a legal claim, 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.

Event Description

It's reported by the attorney, through the filing of a legal claim, 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.

• Brand Name: RADIO CAPITELLUM, RECON HEAD, SIZE #2
• Type of Device: PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9960632
• MDR Text Key: 191982694
• Report Number: 0008031020-2020-01279
• Device Sequence Number: 1
• Product Code: JDB
• UDI-Device Identifier: 00886385026008
• UDI-Public: 00886385026008
• Combination Product (y/n): N
• PMA/PMN Number: K060038
• 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 Model Number: 410-0007
• Device Catalogue Number: 4100007
• Device Lot Number: 36207001
• 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