MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON MB PATELLA PA A38; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5554L381

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Date 07/18/2016

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer due to hospital policy.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

Patient complaint of knee pain.

Manufacturer Narrative

An event regarding fracture involving a triathlon mb patellar component was reported.The event was confirmed.Method & results: device evaluation and results: a photograph of the articulating surface of the poly section of the explanted mb patellar component was provided.The poly component is fractured with a segment of the device missing.Medical records received and evaluation: clinician review of the x-rays and medical records provided indicated that complex mal-alignment and malposition of devices (baseplate and femoral component certainly) has contributed to instability in the knee with pain while also contributing to overload in the patello-femoral joint with patellar device damage.Device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.Complaint history review: complaint history review confirmed that there have been no other similar events for the reported lot.Conclusion: clinician review of the x-rays and medical records provided indicated that complex mal-alignment and malposition of devices (baseplate and femoral component certainly) has contributed to instability in the knee with pain while also contributing to overload in the patella femoral joint with patellar device damage.Further information such as device evaluation is needed to complete the investigation for determining a root cause.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient complaint of knee pain.

• Brand Name: TRIATHLON MB PATELLA PA A38
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5878293
• MDR Text Key: 52174845
• Report Number: 0002249697-2016-02602
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• 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: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• 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: 5554L381
• Device Lot Number: SNLLJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2010
• 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: 76 YR
• Patient Weight: 95