MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MODULAR DUAL MOBILITY INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 626-00-42E

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

Patient Problems Device Embedded In Tissue or Plaque (3165); No Information (3190)

Event Date 09/10/2020

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.

Event Description

As reported: "patient had robotic total hip surgery in the morning and had to be returned to the or that evening for emergent revision surgery due to dislocation of the metal acetabular liner.Determined that the patient had an 'osteophyte from the 5 to 7 o'clock position with the inferior aspect of the metal acetabular liner was incarcerated which prevented the acetabular liner from fully seating in.".

Event Description

As reported: "patient had robotic total hip surgery in the morning and had to be returned to the or that evening for emergent revision surgery due to dislocation of the metal acetabular liner.Determined that the patient had an 'osteophyte from the 5 to 7 o'clock position with the inferior aspect of the metal acetabular liner was incarcerated which prevented the acetabular liner from fully seating in." update: "the product didn¿t fail.We noticed it on his post op films that it wasn¿t in correctly.

Manufacturer Narrative

Reported event: an event regarding disassociation involving an unknown shell was reported.The event was not confirmed.Method & results:-device evaluation and results: visual, dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review:no medical records were received for review with a clinical consultant.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the event could not be confirmed nor the exact cause could be determined because insufficient information was provided.Additional information including device details, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: MODULAR DUAL MOBILITY INSERT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10987755
• MDR Text Key: 220900958
• Report Number: 0002249697-2020-02639
• Device Sequence Number: 1
• Product Code: MEH
• 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: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 626-00-42E
• Device Lot Number: 77224503
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention