GMK FIXED UC LINER SIZE 6, 10 MM.

Report

• Report Number: 3005180920-2014-00026
• Event Type: Injury
• Date Received: March 14, 2014
• Manufacturer: MEDACTA INTERNATIONAL, SA
• Product Code: JWH
• PMA / PMN Number: K090988
• Report Source: Manufacturer report

Narratives

Additional Manufacturer Narrative · 1

DOCUMENT REVIEW: GMK PRIMARY UC LINER SIZE 6, 10 MM: REF. (B)(4) / LOT 111414 ((B)(4) LINERS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. TWELVE LINERS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.

Description of Event or Problem · 1

REFERENCE IMPORTER REPORT # (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
152821	GMK FIXED UC LINER SIZE 6, 10 MM.	FIXED UC TIBIAL INSERT	JWH	MEDACTA INTERNATIONAL, SA

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 1

• No Code Available

Product problems · 1

• Unstable

Source type · 1

• Other

Type of report · 1

• Initial submission