MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX MODULAR ENDO HEAD 45MM; HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS.

Catalog Number	6942-5-045
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the product history records indicates products were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that during a primary implant procedure for patient's right hip, implant was opened.Outer packaging was intact with no damage.Nurse reported that the outer blister was torn.Surgical tech reported that the inner blister was torn.Surgeon elected to not use the implant due to sterility concerns.As a second implant was immediately available, the procedure was completed successfully with no surgical delay and no adverse affects to the patient.
Additional Manufacturer Narrative
An event regarding packaging issue involving a unitrax endoprosthesis head component was reported.The event was confirmed.Device evaluation and results: the box, outer and inner blisters, outer and inner tyvek sheets, product labels and patient labels were returned.There was no damage found on the product box.The inner blister was assembled to the drawing configuration, (b)(4).There was a tear on the inner and outer tyvek sheets that lined up along the rim of the taper of the head.Medical records received and evaluation: not performed as medical records were not provided for review.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 or for the product families indicated on the drawing configuration.Conclusions: the event was confirmed as per the visual inspection of the returned packaging however, the root cause could not be determined.It was confirmed by the packaging team that the product was assembled according to the packaging configuration, (b)(4).No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.
Event or Problem Description
It was reported that during a primary implant procedure for patient's right hip, implant was opened.Outer packaging was intact with no damage.Nurse reported that the outer blister was torn.Surgical tech reported that the inner blister was torn.Surgeon elected to not use the implant due to sterility concerns.As a second implant was immediately available, the procedure was completed successfully with no surgical delay and no adverse affects to the patient.

• Brand Name: UNITRAX MODULAR ENDO HEAD 45MM
• 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: 6865273
• Report Number: 0002249697-2017-02772
• Device Sequence Number: 637072
• Product Code: KWL
• UDI-Device Identifier: 07613327032390
• UDI-Public: 07613327032390
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K014226
• 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): 12/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/17/2022
• Device Catalogue Number: 6942-5-045
• Device Lot Number: HH3XE3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Initial Date Received by Manufacturer: 08/17/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 12/26/2017
• 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: Other
• Patient Age: 82 YR