MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MCK TIBIAL ONLAY INSERT-SZ 7-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180707-1

Device Problems Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 12/29/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

It was reported that surgeon revised patient's right uni compartmental knee due to infection.Surgeon swapped poly and noted that the poly was very worn for an implant that was only implanted 8 weeks prior.

Manufacturer Narrative

An event regarding infection involving a mck tibial onlay insert-sz 7-8mm was reported.The event was not confirmed.Method and results: device evaluation and results: no devices were returned but based on photographs provided, the insert appears worn on the articulating surface and has scratching, burnishing and indentation marks.Medical records received and evaluation: not performed as no medical records were made available.Device history review: a review of the device history records could not be performed as no lot information was provided.Complaint history review: a complaint history review could not be performed as no lot information was provided.Conclusions: the source of the infection could not be determined as patient information, clinical history, and results of bloodwork for infection were not provided.No further investigation for this event is possible at this time as insufficient information was received.If additional information becomes available, this investigation will be reopened.

Event Description

It was reported that surgeon revised patient's right uni compartmental knee due to infection.Surgeon swapped poly and noted that the poly was very worn for an implant that was only implanted 8 weeks prior.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 7-8MM
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5389121
• MDR Text Key: 36804018
• Report Number: 3005985723-2016-00041
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 180707-1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2015
• Initial Date FDA Received: 01/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/09/2016
• 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: 51 YR