MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CROSSFIRE ECCENTRIC INSERT 20; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	S-2302C-3250
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	05/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported relevant discrepancies.There have been no other similar events for the lot referenced.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
Patient dislocated left hip due to locking mechanism failure, specifically the locking wire.Replaced liner and head.
Additional Manufacturer Narrative
An event regarding locking mechanism failure and dislocation involving an omnifit liner was reported.The event relating to the locking mechanism failure was confirmed, as per medical review, however, the dislocation was not.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: a review of the provided x-ray by a clinical consultant indicated: review of these records confirms failure of the metallic wire acetabular locking mechanism occurred, however, the root cause cannot be determined as insufficient information was available for review.The events of dislocation and revision tha cannot be confirmed as insufficient information has been received for review.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including: operative reports.Surgical implant records from the surgeries.Dated pre and post op xrays from the index and revision surgeries.Outpatient office/clinic notes.Implant retrieval are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Patient dislocated left hip due to locking mechanism failure, specifically the locking wire.Replaced liner and head.

• Brand Name: CROSSFIRE ECCENTRIC INSERT 20
• 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: 7637830
• Report Number: 0002249697-2018-01965
• Device Sequence Number: 19461084
• Product Code: JDI
• UDI-Device Identifier: 07613327023312
• UDI-Public: 07613327023312
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K974685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2018

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: 01/31/2021
• Device Catalogue Number: S-2302C-3250
• Device Lot Number: 191976
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 07/04/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 08/02/2018
• 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