MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM BEAD PA SZE5 BP; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number 5526B500

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Injury (2348)

Event Date 09/27/2018

Event Type  Injury  

Manufacturer Narrative

The following lot numbers were listed for the same device: lot# ss8rx; manufacturing date: 05-may-2010; expiration date; 31-may-2015.Lot# sttlt; manufacturing date: 02-july-2010; expiration date; 31-july-2015.The event does not indicate which lot number corresponds with the product reported.Therefore, both are being included, as part of the investigation.An event regarding malposition involving a triathlon baseplate component was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the device was not returned.Medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: complex malalignment of components including an oblique joint space between femur and tibia, likely femoral rotatory malposition and patellofemoral malalignment with lateral tilt/shift have contributed to an overload condition in the pf joint resulting ultimately in disassociation between patellar metal-backing and poly requiring revision surgery.Tibio-femoral instability was possibly an additional but secondary indicator for revision as caused by the oblique joint space with tibial bearing wear, not explicitly evident from the available documentation.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies (both lot ids provided).Complaint history review: there have been no other similar events for the lot referenced (both lot ids provided).Conclusions: further information such as product evaluation, ct scans, revision operative reports, patient history, follow-up notes are 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.Product surveillance will continue to monitor for trends.

Event Description

It was reported that patient's right knee was revised due to pain.Rep provided primary operative and webops report, vitals, and pre-revision x-rays and reported that additional x-rays, medical records, and further information are not available due to hospital policy.Update based on clinical review findings ar 4dec2018: complex malalignment of components including an oblique joint space between femur and tibia, likely femoral rotatory malposition and patellofemoral malalignment with lateral tilt/shift have contributed to an overload condition in the pf joint resulting ultimately in disassociation between patellar metal-backing and poly requiring revision surgery.

• Brand Name: TRIATHLON PRIM BEAD PA SZE5 BP
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8209339
• MDR Text Key: 131840223
• Report Number: 0002249697-2019-00003
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327041378
• UDI-Public: 07613327041378
• 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
• Report Date: 01/02/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 5526B500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 01/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 78 MO
• Patient Weight: 93