MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 32MM ID

Catalog Number	623-10-32F
Medical Device Problem Codes	Packaging Problem (3007); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the product history records indicate 31 devices were manufactured and accepted into final stock on (b)(6) 2017 with no reported relevant discrepancies.Based on the device identification the complaint databases were reviewed for similar reported events regarding packaging issue.Lot id - there have been no other events for the lot referenced.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.Not available.
Event or Problem Description
The customer reported that the surgeon, (b)(6), was undertaking a hip procedure and on opening the package for the trident liner noticed that there was a sticky residue on the package between the paper layer and the plastic outer packaging.The implant was used to complete the case.

• Brand Name: TRIDENT 10° X3 INSERT 32MM ID
• Common Device Name: TRIDENT 10° X3 INSERT 32MM ID
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8050799
• Report Number: 0002249697-2018-03658
• Device Sequence Number: 13837877
• Product Code: LPH
• UDI-Device Identifier: 07613327039863
• UDI-Public: 07613327039863
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K033716
• 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
• Report Date (Section B): 11/08/2018

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: 10/30/2022
• Device Catalogue Number: 623-10-32F
• Device Lot Number: HY26X5
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 11/08/2018
• 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