MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM BEAD PA SZE4 BP; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5526B400

Device Problems Malposition of Device (2616); Positioning Problem (3009)

Patient Problem Injury (2348)

Event Date 09/09/2017

Event Type  Injury  

Manufacturer Narrative

An event regarding wear involving an insert was reported.Baseplate the event was confirmed.Conclusions: a review of the provided medical records and x-rays by a clinical consultant indicated: baseplate malposition in high posterior tibial slope has contributed to flexion instability with overload in the arthroplasty and consequently abnormal bearing wear requiring revision with tibial bearing exchange.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Not returned.

Event Description

Insert change due to poly wear.Update: per medical review "baseplate malposition in high posterior tibial slope has contributed to flexion instability with overload in the arthroplasty and consequently abnormal bearing wear requiring revision with tibial bearing exchange.".

Manufacturer Narrative

Additional information: common device name; lot #; expiration date; initial reporter type ¿ other; manufacturing date.An event regarding malposition involving a baseplate was reported.The event was confirmed.Method & results: device evaluation and results: not performed as product was not returned medical records received and evaluation: a principal contributor to the present knee instability was the relatively high posterior tibial slope of the baseplate with an angle of 8°.Under normal implantation conditions, this should never be more than 5°, usually between 0° - 5°.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.Conclusions: a review of the provided medical records and x-rays by a clinical consultant indicated: baseplate malposition in high posterior tibial slope has contributed to flexion instability with overload in the arthroplasty and consequently abnormal bearing wear requiring revision with tibial bearing exchange.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

Insert change due to poly wear.Update: per medical review "baseplate malposition in high posterior tibial slope has contributed to flexion instability with overload in the arthroplasty and consequently abnormal bearing wear requiring revision with tibial bearing exchange.".

• Brand Name: TRIATHLON PRIM BEAD PA SZE4 BP
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7182881
• MDR Text Key: 96990516
• Report Number: 0002249697-2018-00135
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 02/13/2018

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 Expiration Date: 09/30/2018
• Device Catalogue Number: 5526B400
• Device Lot Number: EEFLP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2017
• Initial Date FDA Received: 01/11/2018
• Supplement Dates Manufacturer Received: 01/18/2018
• Supplement Dates FDA Received: 02/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 81