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

Catalog Number	626-00-52H
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	02/05/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
An event regarding loosening and dislocation and implantation of competitor stem and head involving a liner 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 or Problem 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: MODULAR DUAL MOBILITY INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9307403
• Report Number: 0002249697-2019-03733
• Device Sequence Number: 2030853
• Product Code: LZO
• UDI-Device Identifier: 04546540666048
• UDI-Public: 04546540666048
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K103233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: 626-00-52H
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 80