MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH OMNIFIT SER. II INSERT 20 DEG.; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	2042-2654
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	04/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported 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.Device not returned.
Event or Problem Description
Patient hip dislocating, liner and head explanted.Re-implanted new head, liner, and screw.
Additional Manufacturer Narrative
An event regarding dislocation involving a omnifit liner was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the device was not returned.Clinician review: the available medical records were provided to a consulting clinician for a review which was deemed insufficient stating - "provided x-ray does not confirm the reported event but notes acetabular shell is vertical.Need operative reports, office/clinical reports, serial x-rays, and examination of the explanted components." 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: it was reported that the patient's hip was revised due to dislocation.The available medical records were provided to a consulting clinician for a review which was deemed insufficient stating that provided x-ray does not confirm the reported event but notes acetabular shell is vertical.Need operative reports, office/clinical reports, serial x-rays, and examination of the explanted components.The event could not be confirmed nor the exact cause of the event be determined because insufficient information was provided.Additional information, including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Product surveillance will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.
Event or Problem Description
Patient hip dislocating, liner and head explanted.Reimplanted new head, liner, and screw.Update 15/may/2019: clinician review "notes acetabular shell is vertical.".

• Brand Name: OMNIFIT SER. II INSERT 20 DEG.
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8565446
• Report Number: 0002249697-2019-01764
• Device Sequence Number: 14017477
• Product Code: LPH
• UDI-Device Identifier: 04546540036063
• UDI-Public: 04546540036063
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K943054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1988
• 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): 06/13/2019

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: 10/31/1995
• Device Catalogue Number: 2042-2654
• Device Lot Number: ABEO
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 06/13/2019
• 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: 52 YR