MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS PROXIMAL TIBIAL STANDARD PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 64953102

Device Problem Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other similar events for the reported lot. When completed, the evaluation summary will be submitted in a supplemental report.

Event Description

Standard proximal tibia (gmrs) 6495-3-102 was opened in the operating room. The non-sterile outer packaging was removed from the implant box. When peeling open the outer package to expose the inner sterile package, part of the outer plastic package was torn away with the peel away paper top. The inner sterile package appeared to be undamaged. Upon opening the inner sterile package, debris was found in around the proximal tibial implant. The debris appeared to be little white fibers or small particles of the paper seal from the inner sterile package. Questions arose regarding the integrity of the outer packaging and the subsequent sterility of the implant within the inner package. Surgeon decided not to implant the standard proximal tibia. The small proximal gmrs segment was substituted out of necessity. Tourniquet was inflated for 120 minutes, deflated for 20, then reinflated for 30 additional minutes, total tourniquet time 150 minutes.

• Brand Name: GMRS PROXIMAL TIBIAL STANDARD
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: joann lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8367785
• MDR Text Key: 137378563
• Report Number: 0002249697-2019-01180
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 64953102
• Device Lot Number: 068838R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/25/2019 Patient Sequence Number: 1