MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX MODULAR ENDO HEAD 45MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number	6942-5-045
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	05/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Opened sterilized implant, was sitting on table for a while but then noticed a white product on inside of unitrax head.Does not believe cement was on it.
Additional Manufacturer Narrative
An event regarding a foreign matter involving an other hip head was reported.The event was confirmed.Method & results: -device evaluation and results: material analysis report concluded: "the white product on the head was found to be likely bone cement.No material or manufacturing defects were observed on the surfaces examined." -medical records received and evaluation: not performed as it was reported that there were no adverse consequences nor medical intervention.- device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.- complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the event reported for a white product on inside of unitrax head.The event was confirmed on the basis of visual inspection and material analysis report.The material analysis report concluded that the white product on the head was found to be likely bone cement.No material or manufacturing defects were observed on the surfaces examined.If the additional information are received, this investigation will be reopened and re-evaluated.
Event or Problem Description
Opened sterilized implant, was sitting on table for a while but then noticed a white product on inside of unitrax head.Does not believe cement was on it.

• Brand Name: UNITRAX MODULAR ENDO HEAD 45MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6645750
• Report Number: 0002249697-2017-01894
• Device Sequence Number: 11076388
• Product Code: KWL
• UDI-Device Identifier: 07613327032390
• UDI-Public: 07613327032390
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K014226
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2018

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: 01/03/2022
• Device Catalogue Number: 6942-5-045
• Device Lot Number: MP5E9X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Initial Date Received by Manufacturer: 05/19/2017
• Supplement Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 06/15/2017
• Supplement Report FDA Received Date: 01/04/2018
• 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