MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH OMNIFIT SER. II INSERT-10 DEG.; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	2041-2850
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available, it will be reported in a supplemental report upon completion of the investigation.Device not returned to the manufacturer.
Event or Problem Description
It was reported, patient had left hip revision.Head and liner exchange of series 2 liner and c-taper head.Update 10/19/2018: the reason for revision was an unstable hip.
Additional Manufacturer Narrative
Additional information lot code.An event regarding instability involving an omnifit liner was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the device was not returned for evaluation.-medical records received and evaluation: a review of the provided x-ray by a clinical consultant indicated: " still not enough information to justify the revision including history and x-rays of dislocations, exam of explanted components, operative reports, and clinical and past medical records." -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.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device details, history and x-rays of dislocations, exam of explanted components, operative reports, and clinical and past medical records are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.
Event or Problem Description
It was reported, patient had left hip revision.Head and liner exchange of series 2 liner and c-taper head.Update 10/19/2018: the reason for revision was an unstable hip.

• Brand Name: OMNIFIT SER. II INSERT-10 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: 8059872
• Report Number: 0002249697-2018-03690
• Device Sequence Number: 1697003
• Product Code: LPH
• UDI-Device Identifier: 04546540035387
• UDI-Public: 04546540035387
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K943054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1993
• 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): 02/12/2019

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: 03/31/1998
• Device Catalogue Number: 2041-2850
• Device Lot Number: AMJT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 02/12/2019
• 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: 85 YR
• Patient Weight: 63