MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_SIMPLEX P CEMENT 2 OF 2; BONE CEMENT

Catalog Number UNK_LIM

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348); Inadequate Osseointegration (2646)

Event Date 08/14/2019

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding loosening involving a unknown simplex cement mix was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: need operative reports, office/clinical reports, serial x-rays, etc.Product history review: not performed as the lot details were not provided.Complaint history review: not performed as the lot details were not provided.Conclusions: the reported event was not confirmed and the exact cause of the event could not be determined because insufficient information was provided.Further information such as product id, operative reports, office/clinical reports and serial x-rays are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that the patient's right knee was revised due to pain and loss of function.Intra operatively, the following was noted: the size 5 cemented femoral component was loose; there was a fracture at the junction of the femoral stem and 12x100 stem; the cemented tibial component was loose; the junction of the stem extender and 12x50 stem on the tibial side was loose.The patient's entire ts knee construct (including five augments) was revised to a triathlon ts knee construct with a cone.Rep provided one page of the primary operative report, and reported that no further information will be released by the hospital or surgeon.

• Brand Name: UNKNOWN_SIMPLEX P CEMENT 2 OF 2
• Type of Device: BONE CEMENT
• 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: joanne mahony ; ida industrial estate; carrigtwohill NA ; 214532800
• MDR Report Key: 8982213
• MDR Text Key: 161565673
• Report Number: 0002249697-2019-03164
• Device Sequence Number: 1
• Product Code: LOD
• 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,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/10/2019

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: UNK_LIM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 09/10/2019
• 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: 72 YR