MAUDE Adverse Event Report: STRYKER GMBH RADIAL HEAD IMPLANT #4 (STERILE PACKED); ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS

Catalog Number	RHAH4
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2002
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device not available.
Event or Problem Description
The manufacturer became aware of adverse events from the (b)(6) arthroplasty register ((b)(6)).The title of this report is ¿rhead reported in the (b)(6) arthroplasty register ((b)(6))¿ which is associated with the rhead system, within that report, post-operative complications/adverse events were reported, which occurred between 2002 and 2017.A review of the complaint handling database revealed that the events have not been reported previously to stryker, therefore 3 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses revision surgery due to loosening of the distal component in 2007.

• Brand Name: RADIAL HEAD IMPLANT #4 (STERILE PACKED)
• Common Device Name: ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7923918
• Report Number: 0008031020-2018-00687
• Device Sequence Number: 19194867
• Product Code: KWI
• UDI-Device Identifier: 00886385024684
• UDI-Public: 00886385024684
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K002644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/01/2018

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 Catalogue Number: RHAH4
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 10/01/2018
• 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: 42