UNKNOWN_SELZACH_PRODUCT

Report

• Report Number: 0008031020-2015-00463
• Event Type: Injury
• Date Received: November 19, 2015
• Date of Event: November 3, 2015
• Report Date: November 3, 2015
• Manufacturer: STRYKER GMBH
• Product Code: NTG
• PMA / PMN Number: P050050
• Adverse Event: Yes
• Product Problem: Yes
• Report Source: Manufacturer report
• Reporter Location: PA, US
• Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE REPORTED DEVICE WAS MANUFACTURED AND DISTRIBUTED BY (B)(4) AND IMPLANTED PRIOR TO HOWMEDICA OSTEONICS CORP.¿S PURCHASE OF CERTAIN ASSETS OF (B)(4) ON (B)(4) 2014. STRYKER BECAME LEGAL MANUFACTURER OF THIS PRODUCT ON (B)(4) 2015 AND HAS TAKEN THE RESPONSIBILITY FOR MEDICAL DEVICE REPORTING. UNKNOWN STAR TALAR COMPONENT.

Description of Event or Problem · 1

A STAR WAS TAKEN OUT AND A T2 ANKLE NAIL WAS PUT IN. PATIENT HAD PAIN AFTER TOTAL ANKLE REPLACEMENT AND WANTED IT TAKEN OUT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
765262	UNKNOWN_SELZACH_PRODUCT	PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME	NTG	STRYKER GMBH		UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	70		Required Intervention

Terms

Patient problem · 1

• Pain

Product problems · 1

• Adverse Event Without Identified Device or Use Problem

Source type · 1

• COMPANY REPRESENTATIVE