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

Model Number	2042-2646
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
The wire on the series ii liner was broken.Doctors claim that the implant itself may be defective.However, there is a possibility that the wire may be damaged by micromotion on the inner surface of the cup or the outer surface of the liner due to damage over time or defective driving.
Additional Manufacturer Narrative
Corrected event type to serious injury.
Event or Problem Description
The wire on the series ii liner was broken.Doctors claim that the implant itself may be defective.However, there is a possibility that the wire may be damaged by micromotion on the inner surface of the cup or the outer surface of the liner due to damage over time or defective driving.

• 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: 10353873
• Report Number: 0002249697-2020-01574
• Device Sequence Number: 16854637
• Product Code: LPH
• UDI-Device Identifier: 04546540036049
• UDI-Public: 04546540036049
• Combination Product (Y/N): N
• PMA/510(K) Number: K943054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2042-2646
• Device Catalogue Number: 2042-2646
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 08/05/2020
• 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: Other; Required Intervention