MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN RAS SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNK_JR

Device Problems Osseointegration Problem (3003); Insufficient Information (3190)

Patient Problems Injury (2348); Inadequate Osseointegration (2646); No Information (3190)

Event Date 02/05/2019

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

(b)(6) 2016: ras implanted.Complex revision for pelvic discontinuity.Patient had 4 revisions prior to this, history of ra.(b)(6) 2018: patient seen in clinic and reported that she felt hip shift and dislocate.Loosening of acetabular cup identified on x-ray.Radiology report: slight distraction of the acetabular screws in comparison to the previous examination that would be consistent.(b)(6) 2019: removal of acetabulum implant and femoral head exchange to bipolar implant.Patient factors: sedentary, wheelchair bound, history of recurrent dislocation.Competitor stem and head noted in per product grid.

Manufacturer Narrative

An event regarding loosening and dislocation and implantation of competitor stem and head involving a unknown shell was reported.Conclusion: it was reported that patient felt hip shift and dislocate, loosening of accetabular cup also identified.Competitor head and stem also noted in per product grid.It was reported that competitor head and stem was used with stryker component.Based on the provided information it has been determined that this event is associated with an off-label application.As per ifu only stryker product are compatible with stryker component, using styker component with competitor consider as off label use of products.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

On (b)(6) 2016: ras implanted.Complex revision for pelvic discontinuity.Patient had 4 revisions prior to this, history of ra.On (b)(6) 2018: patient seen in clinic and reported that she felt hip shift and dislocate.Loosening of acetabular cup identified on x-ray.Radiology report: slight distraction of the acetabular screws in comparison to the previous examination that would be consistent.On (b)(6) 2019: removal of acetabulum implant and femoral head exchange to bipolar implant.Patient factors: sedentary, wheelchair bound, history of recurrent dislocation.Competitor stem and head noted in per product grid.

• Brand Name: UNKNOWN RAS SHELL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9307393
• MDR Text Key: 173930167
• Report Number: 0002249697-2019-03732
• Device Sequence Number: 1
• Product Code: LPH
• 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: 01/09/2020

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_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 11/11/2019
• Supplement Dates Manufacturer Received: 12/11/2019
• Supplement Dates FDA Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 80