MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN RADIAL HEAD; IMPLANT

Catalog Number UNK_SEL

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 11/15/2018

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device disposition is unknown.

Event Description

It was reported through a medwatch: "patient underwent radial head replacement with a stryker radial head on 2016.Approximately 2 years later, he was using his arm for a regular activity and had immediate pain.X-rays showed that the modular head had partially disengaged from the stem".Patient was revised on (b)(6) 2018.

• Brand Name: UNKNOWN RADIAL HEAD
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8257046
• MDR Text Key: 133361430
• Report Number: 0008031020-2019-00036
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention