MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX MODULAR ENDO HEAD 47MM; HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS.

Catalog Number	6942-5-047
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	12/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: unitrax c-taper sleeve +0mm; cat#:6942-7-065; lot#:56633201.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.
Event or Problem Description
The patient's right hip was revised due to infection.
Additional Manufacturer Narrative
An event regarding infection involving a unitrax femoral head was reported.The event was not confirmed.Method and results: device evaluation and results: not performed as the device was not returned.Medical records received and evaluation: not performed as no medical records were received for review with a clinical consultant.Device history review: review of the device history records indicates all devices were accepted into final stock with no relevant discrepancies complaint history review: there have been no other similar events for the reported lot and sterile lot.Conclusions: the exact cause of the event could not be determined because insufficient information was received.Further information such as return of device, pathology reports, x-rays, operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.If additional information and/or device become available, this investigation will be reopened.
Event or Problem Description
The patient's right hip was revised due to infection.

• Brand Name: UNITRAX MODULAR ENDO HEAD 47MM
• 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: 6242991
• Report Number: 0002249697-2017-00178
• Device Sequence Number: 19021532
• Product Code: KWL
• UDI-Device Identifier: 07613327032420
• UDI-Public: (01)07613327032420(11)160427(17)210430(10)A48K7D
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2017

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: 04/30/2021
• Device Catalogue Number: 6942-5-047
• Device Lot Number: A48K7D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2017
• Supplement Report FDA Received Date: 03/14/2017
• 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: 78 YR
• Patient Weight: 78