MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX MODULAR ENDO HEAD 51MM; HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS

Model Number	6942-5-051
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374); Cancer (3262)
Date of Event	04/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
Patient had a proximal femoral uni polar replacement nine months ago and recently started to dislocate.
Additional Manufacturer Narrative
Additional information: executive summary.An event regarding loosening involving a unitrax modular endo head 51mm was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the device was not returned.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned and insufficient information was provided.It was reported that the patient had cancer which could have been a contributing factor to the alleged loosening however, further information is required to investigate this event further.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
Event or Problem Description
Patient had a proximal femoral uni polar replacement nine months ago and recently started to dislocate.Update as per sales rep: spoke to sales rep and he confirmed that the patient had cancer.The unipolar head loosened from the acetabulum.

• Brand Name: UNITRAX MODULAR ENDO HEAD 51MM
• Common Device Name: HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6591518
• Report Number: 0002249697-2017-01669
• Device Sequence Number: 10854987
• Product Code: KWL
• UDI-Device Identifier: 07613327032451
• UDI-Public: (01)07613327032451(11)160104(17)210131(10)M04APW
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K014226
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2017

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 Model Number: 6942-5-051
• Device Catalogue Number: 6942-5-051
• Device Lot Number: M04APW
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2017
• Supplement Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 05/25/2017
• Supplement Report FDA Received Date: 08/14/2017
• 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: 19 YR