MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ABC ALUMINA CERAMIC INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number 2047-2844

Device Problems Fracture (1260); Unstable (1667)

Patient Problem Injury (2348)

Event Date 11/22/2018

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding revision due to crack/fracture involving a veramiv liner was reported.The event was confirmed through visual inspection of the provided photograph.Method & results: product evaluation and results: the reported device was not returned; however, two photographs were provided for review.One "photgraphs" shows a ceramic liner; the liner appears damaged/fractured along the rim.One photograph shows the head placed/seated into the ceramic liner.Part of the liner is missing.Clinician review: no medical records were received for review with a clinical consultant.Product history review: not performed as no lot information was provided.Complaint history review: not "perofrmed" as no lot information was provided.Conclusions: the exact cause of the event could not be confirmed as insufficient information was provided.Further information such as device lot information, product return pre and post operative x-rays, operative reports as well as patient history and follow up notes are required to complete the investigation for determining a root cause.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

The tha was done with alumina ceramic liner and head.It was later reported that the patient felt wobbling of the hip joint.The broken liner was confirmed, and revision surgery was performed.A broken part was removed, but it seems that all parts have not been collected.

• Brand Name: ABC ALUMINA CERAMIC INSERT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• 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: anna smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8180575
• MDR Text Key: 130888149
• Report Number: 0002249697-2018-04083
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: P000013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2047-2844
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2018
• 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; Other; Required Intervention
• Patient Age: 77 YR