MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_LIM_PRODUCT; HIP IMPLANT

Catalog Number UNK_LIM

Device Problem Loss of Osseointegration (2408)

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

Event Date 05/30/2018

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested and if received will be provided in a supplemental report.

Event Description

Originally a pca stem and vita lock cup were used.The patient last year had a periprosthetic fracture where the head and liner were changed and the femur was plated and cabled.The patient is now experiencing loosening of the stem.Surgeon wants to remove stem head and liner and replace them.

Event Description

Originally a pca stem and vita lock cup were used.The patient last year had a periprosthetic fracture where the head and liner were changed and the femur was plated and cabled.The patient is now experiencing loosening of the stem.Surgeon wants to remove stem head and liner and replace them.Review of these records confirms a tha periprosthetic femoral fracture with concomitant or subsequent loosening of the stem and revision surgery did occur.

Manufacturer Narrative

An event regarding loosening involving a unknown stem was reported.The event was confirmed by medical review.Method & results: -product evaluation and results: not performed as the device was not returned.-medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: conclusion of assessment review of these records confirms a tha periprosthetic femoral fracture with concomitant or subsequent loosening of the stem and revision surgery did occur however, the details and root cause cannot be determined as insufficient information was available further documentation which would aid in the completion of this assessment includes: ¿ operative reports from the orif of the periprosthetic tha fracture and the revision tha ¿ dated pre and post op x-rays/ imaging from the index, orif and revision surgeries ¿ outpatient office/clinic notes ¿ implant retrieval -product history review: not performed as the device lot details were not provided.-complaint history review: not performed as the device lot details were not provided.Conclusions: review of these records confirms a tha periprosthetic femoral fracture with concomitant or subsequent loosening of the stem and revision surgery did occur however, the details and root cause cannot be determined as insufficient information was available.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: UNKNOWN_LIM_PRODUCT
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7634954
• MDR Text Key: 112219055
• Report Number: 0002249697-2018-01933
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• 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: 08/01/2018

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 Catalogue Number: UNK_LIM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 06/25/2018
• Supplement Dates Manufacturer Received: 07/06/2018
• Supplement Dates FDA Received: 08/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 67 YR