MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIM BP W/HOLES BEAD W/PA SZ 7; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5527B700

Device Problems Break (1069); Crack (1135); Fracture (1260)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 04/08/2015

Event Type  Injury  

Event Description

It was reported that a stryker employee received a call from a family friend that thinks part of a stryker total knee replacement is broken.Stryker total knee, implanted late last year.His surgeon told him that his tibial implant has cracked in half.Update per sales rep: the patient's knee was being revised because the baseplate cracked in half.

Manufacturer Narrative

Catalogue number unknown at this time.Device description reported as an unknown pa baseplate size 7.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Additional information received indicated that the patient retained an attorney.Not returned to the manufacturer.

Manufacturer Narrative

Device returned, age of patient is (b)(6) years.Reported event: an event regarding crack/fracture involving a triathlon baseplate was reported.The event was confirmed.Method & results: device evaluation and results: a material analysis concluded: the tibial tray broke in fatigue.The loss of support under the insert caused the insert to break at the same location as the tray.The metallic particles observed in the insert were consistent with beads that came loose when the tray broke.The base material of the tray was a co-cr-mo alloy consistent with an astm f75 material.No material or manufacturing defects were observed on the surfaces examined.Medical records received and evaluation: review of medical records by a consulting clinician indicated: in this markedly obese patient, the unsupported (either by a bony defect and/or inadequate contact with the host bone at this site) posteromedial tibial plateau in this uncemented component was cyclicly loaded and eventually led to fatigue fracture at the junction of the supported and unsupported portions of the tray.Once fractured, the unsupported fragment subsided into the tibia and the insert fractured by the same mechanism.There is no evidence that factors of faulty component design, manufacturing or materials were responsible for this clinical situation.Device history review: indicates all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the material analysis report (mar) indicated: the tibial tray broke in fatigue.The loss of support under the insert caused the insert to break at the same location as the tray.The metallic particles observed in the insert were consistent with beads that came loose when the tray broke.The base material of the tray was a co-cr-mo alloy consistent with an astm f75 material.No material or manufacturing defects were observed on the surfaces examined.The medical review indicated: in this markedly obese patient, the unsupported (either by a bony defect and/or inadequate contact with the host bone at this site) posteromedial tibial plateau in this uncemented component was cyclicly loaded and eventually led to fatigue fracture at the junction of the supported and unsupported portions of the tray.Once.Fractured, the unsupported fragment subsided into the tibia and the insert fractured by the same mechanism.There is no evidence that factors of faulty component design, manufacturing or materials were responsible for this clinical situation.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

It was reported that a stryker employee received a call from a family friend that thinks part of a stryker total knee replacement is broken.Stryker total knee, implanted late last year.His surgeon told him that his tibial implant has cracked in half.Update per sales rep: the patient's knee was being revised because the baseplate cracked in half.

• Brand Name: PRIM BP W/HOLES BEAD W/PA SZ 7
• 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 NJ NA
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4745666
• MDR Text Key: 5887625
• Report Number: 0002249697-2015-01426
• 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: Other,Consumer,consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 5527B700
• Device Lot Number: S9DLA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2012
• 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: 70 YR
• Patient Weight: 153