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

Model Number	2041C-2846
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/13/2009
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding dislocation involving an omnifit liner was reported.A clinical review confirmed the event of dislocation and wear.Method & results: device evaluation and results: a visual, dimensional, functional and material analysis inspection was not performed as the device was not returned for evaluation.-medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: ".The operative report states the patient was doing well until several months previously when she dislocated her hip, which was apparently on (b)(6) 2009, for which she underwent a closed reduction.An x-ray was described as demonstrating eccentric wear.The operative report also states that the sales representative was supposed to bring in a constrained liner but it was not available in the operating room so a new 28/10° insert and a 28/plus-5 head were inserted with good stability described.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." device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been one other event for the lot referenced, however, it is for the same patient.Conclusions: a medical review confirmed that the wear of the liner and dislocation was a result of the shell positioning as noted "more vertical than normal" and "during this surgery inherent instability of a 10° constrained liner further suggests the malposition of the acetabular shell".No further investigation is required at this time.If additional relevant information becomes available, this investigation will be reopened.Device implanted.
Event or Problem Description
Per medical review, patient had a closed reduction on (b)(6) 2009 due to dislocation.Medical review notes: "the operative report states, "acetabulum may be a little more vertical than normal".
Additional Manufacturer Narrative
Corrected data: it was discovered that the selection for b2 was inadvertently missed during the submission of the initial report.B2 has been updated with the appropriate information.Reported event: an event regarding dislocation involving an omnifit liner was reported.A clinical review confirmed the event of dislocation and wear.Method & results: device evaluation and results: a visual, dimensional, functional and material analysis inspection was not performed as the device was not returned for evaluation.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: "the operative report states the patient was doing well until several months previously when she dislocated her hip, which was apparently on (b)(6) 2009, for which she underwent a closed reduction.An x-ray was described as demonstrating eccentric wear.The operative report also states that the sales representative was supposed to bring in a constrained liner but it was not available in the operating room so a new 28/10° insert and a 28/plus-5 head were inserted with good stability described 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." device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been one other event for the lot referenced, however, it is for the same patient.Conclusions: a medical review confirmed that the wear of the liner and dislocation was a result of the shell positioning as noted "more vertical than normal" and "during this surgery inherent instability of a 10° constrained liner further suggests the malposition of the acetabular shell".No further investigation is required at this time.If additional relevant information becomes available, this investigation will be reopened.Product surveillance will continue to monitor for trends.H3 other text : device not returned.
Event or Problem Description
Per medical review, patient had a closed reduction on (b)(6) 2009 due to dislocation.Medical review notes: "the operative report states, "acetabulum may be a little more vertical than normal".

• Brand Name: CROSSFIRE 10 DEG INSERT
• Common Device Name: HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7906982
• Report Number: 0002249697-2018-03020
• Device Sequence Number: 1625109
• 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: 2000
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2020

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 Expiration Date: 05/30/2005
• Device Model Number: 2041C-2846
• Device Catalogue Number: 2041C-2846
• Device Lot Number: 55008801
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 11/24/2020
• 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: Required Intervention
• Patient Age: 53 YR
• Patient Weight: 62