MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #3 RM/LL -8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	5630-G-328
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: triathlon pkr baseplate #3 rm/ll; cat# 5620-b-302; lot# wssra, triathlon pkr femur #4 rm/ll; cat# 5610-f-402; lot# wbwa, triathlon asym patella a35x10; cat# 5551l350; lot# lfh094, it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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 lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device not returned.
Event or Problem Description
This pi is for pain and drainage of the patient's right knee on (b)(6) 2017.In performing a medical review for the revision of the patient's right knee on (b)(6) 2017 , the following findings were reported.On (b)(6) 2017: ¿problems starting early after surgery,¿ residual hemarthrosis, aspiration 3 times, 50-ml blood reportedly removed.On (b)(6) 2017: manipulation under anesthesia on (b)(6) 2017: pain, catching on lateral side of knee, drainage performed (25-ml), no infection.On (b)(6) 2017: persistent pain with recurrent effusions.30-ml drained, no infection.

• Brand Name: TRIATHLON PKR INSERT X3 #3 RM/LL -8MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9185921
• Report Number: 0002249697-2019-03467
• Device Sequence Number: 3448012
• Product Code: HRY
• UDI-Device Identifier: 07613327015980
• UDI-Public: 07613327015980
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/14/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 5630-G-328
• Device Lot Number: XA17M4
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other