MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CROSSFIRE 10 DEG INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	2041C-2846
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	04/11/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicates devices were manufactured and accepted into final stock on with no reported discrepancies.There have been 1 other events for the lot referenced but the reported event is for the same patient.Conclusion: the description of the acetabular component as "more vertical than normal" would suggest an inherently unstable hip that, after some poly wear, dislocated.It was noted on (b)(6) 2001 (four months status-post primary total hip) that the hip was popping in and out of place.The first revision done, in which a constrained liner was not available in the operating room, resulted in persistent instability causing the subsequent revision to a constrained liner two months later.During this surgery inherent instability of a 10° constrained liner further suggests the malposition of the acetabular shell.There is no evidence that factors of faulty prosthetic design, manufacturing, or materials were responsible for this clinical situation.An evaluation of the device cannot be performed as the device was not returned to the manufacturer as it remained implanted.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Not returned to the manufacturer.
Event or Problem Description
On (b)(6) 2010 the patient complained of popping in the hip and on (b)(6) 2010 she sustained a dislocation, which was treated with closed reduction, and the plan was to insert a constrained liner." the operative report states, "acetabulum may be a little more vertical than normal.".

• Brand Name: CROSSFIRE 10 DEG INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7906658
• Report Number: 0002249697-2018-03026
• Device Sequence Number: 11176219
• Product Code: JDI
• UDI-Device Identifier: 04546540035714
• UDI-Public: 04546540035714
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K974685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2014
• Device Catalogue Number: 2041C-2846
• Device Lot Number: 31357401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/25/2018
• 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: 54 YR
• Patient Weight: 62