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

Model Number	410-0007
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 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 or Problem 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.
Additional Manufacturer Narrative
Correction: refer to a2, h6 patient code.
Event or Problem 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
• Common Device Name: PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9960632
• Report Number: 0008031020-2020-01279
• Device Sequence Number: 11366746
• Product Code: JDB
• UDI-Device Identifier: 00886385026008
• UDI-Public: 00886385026008
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K060038
• 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 Model Number: 410-0007
• Device Catalogue Number: 4100007
• Device Lot Number: 36207001
• 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