MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON ASYMMETRIC X3 PATELLA; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number 5551-G-401

Device Problems Break (1069); Fracture (1260); Peeled/Delaminated (1454); Material Integrity Problem (2978)

Patient Problems Pain (1994); Injury (2348)

Event Date 08/10/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device remained implanted in the patient and 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

Patient presented with pain in right knee.Surgeon took x-rays of right knee and upon review discovered what appears to be sheared posts from the implanted triathlon asymetric x3 patella.Surgeon has yet to schedule the revision at this time.

Manufacturer Narrative

An event regarding peg fracture involving a triathlon patella was reported.The event was confirmed.Method & results: -device evaluation and results: the fracture surface was examined by the material analysis team who indicated that the fracture appeared consistent with fatigue.Burnishing and scratching were observed throughout the patella.A localized area of material deformation was observed near the rim of the patella.-medical records received and evaluation: not performed because no records were provided for review.-device history review: all devices accepted into final stock met specification.-complaint history review: there have been no other events for the reported lot.Conclusions: the investigation determined the likely root cause of the fractured patella pegs to be fatigue.There was no evidence of manufacturing or material defects on the returned ultra-high molecular weight polyethylene (uhmwpe) patella.If additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Update as per sales rep: surgeon revised poly and patella on (b)(6).

• Brand Name: TRIATHLON ASYMMETRIC X3 PATELLA
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• 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: 5050190
• MDR Text Key: 24894488
• Report Number: 0002249697-2015-02911
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/10/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 5551-G-401
• Device Lot Number: 4RHK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2013
• 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): Other