MAUDE Adverse Event Report: STRYKER GMBH UHEAD STEM; IMPLANT

Catalog Number UNK_SEL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Rash (2033); Swelling (2091)

Event Date 06/11/2015

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device remains implanted.

Event Description

Consultant hand surgery/orthopaedic surgeon at (b)(6) hospital requested via the sbi distributor, (b)(4), the metal composition of the uhead and remotion implants.The hospital reported that a male, (b)(6) patient, had experienced swelling, a rash and itching ulnar and radial following wrist surgery.It was further reported that the patient underwent surgery using remotion implants on the (b)(6) 2010 and (b)(6) 2014, and underwent surgery using the uhead implants on (b)(6) 2015.It is further reported that the patient has not received any further treatment.The patient reports that he occasionally has a tingling in his mouth and tongue caused by a titanium dental implant that he has.

• Brand Name: UHEAD STEM
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5641563
• MDR Text Key: 44802670
• Report Number: 0008031020-2016-00241
• Device Sequence Number: 1
• Product Code: KXE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2016
• 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: UNKOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2016
• 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
• Patient Age: 71 YR
• Patient Weight: 85