MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #1 LM/RL -8MM; IMPLANT

Catalog Number 5630-G-108

Device Problems No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 06/15/2015

Event Type  Injury  

Event Description

Patient had a triathlon pkr and was revised to a total knee - surgeon stated revision was due to a compromised mcl only no issue with devices.

Manufacturer Narrative

Catalogue number unknown at this time.Device description reported as an unknown tibial insert.The following other devices were also listed in this report: femoral component; cat# unknown; lot# unknown, tibial baseplate; cat# unknown; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.When completed, the investigation results will be submitted in a supplemental report.

Manufacturer Narrative

The following device information for the other devices listed in initial emdr was received after it was submitted: triathlon pkr femur #1 lm/rl; cat# 5610-f-101; lot# unknown.Triathlon pkr baseplate #1 lm/rl; cat# 5620-b-101; lot# bkrka.Conclusion: based on the provided information, the product reported in this investigation did not contribute to the event.It was reported that there was no issue with the devices.The surgeon elected to revise from a partial knee replacement to a total knee replacement due to a compromised mcl.The returned device was unremarkable.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient had a triathlon pkr and was revised to a total knee - surgeon stated revision was due to a compromised mcl only no issue with devices.

• Brand Name: TRIATHLON PKR INSERT X3 #1 LM/RL -8MM
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4901720
• MDR Text Key: 20126209
• Report Number: 0002249697-2015-02262
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082567
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: 5630-G-108
• Device Lot Number: MJR2MD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/10/2010
• 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: 35 YR