MAUDE Adverse Event Report: STRYKER GMBH RADIO CAPITELLUM, RECON HEAD, SIZE #3; PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Model Number 410-0008

Device Problems Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923)

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

Event Date 02/04/2015

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device disposition is unknown.

Event Description

It was reported by the patient's attorney that allegedly following her replacement surgery the patient began to experience increasing pain and decreased function in her elbow and her surgeon confirmed loosening of the radial head prosthesis.It is further alleged that during the revision surgery on (b)(6) 2015 the surgeon found the radial head component to have dislocated/disassociated from the radial stem.Allegedly the radial head component was revised with another stryker radial head component.

Manufacturer Narrative

The reported event that radio capitellum, recon head, size #3 was alleged of 'implant - dislocated' 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 or manufacturing problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported by the patient's attorney that allegedly following her replacement surgery the patient began to experience increasing pain and decreased function in her elbow and her surgeon confirmed loosening of the radial head prosthesis.It is further alleged that during the revision surgery on (b)(6) 2015 the surgeon found the radial head component to have dislocated/disassociated from the radial stem.Allegedly the radial head component was revised with another stryker radial head component.

• Brand Name: RADIO CAPITELLUM, RECON HEAD, SIZE #3
• Type of Device: PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9983789
• MDR Text Key: 191142736
• Report Number: 0008031020-2020-01385
• Device Sequence Number: 1
• Product Code: JDB
• UDI-Device Identifier: 00886385026015
• UDI-Public: 00886385026015
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2016
• Device Model Number: 410-0008
• Device Catalogue Number: 4100008
• Device Lot Number: 22767501
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 8031020-10/24/2017-002R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR