MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNIVERSAL IMPACTOR/POSTIONER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	2101-0200
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.
Event or Problem Description
Primary hip procedure.Rep reported that due to metal spurs on the threads of the inserter, the instrument would not thread into the shell.A second device was immediately available in the o.R.And was used to complete the surgery successfully with no delay.The device is allegedly available for return, and the rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: UNIVERSAL IMPACTOR/POSTIONER
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9343405
• Report Number: 0002249697-2019-03818
• Device Sequence Number: 2166357
• Product Code: LPH
• UDI-Device Identifier: 07613327211511
• UDI-Public: 07613327211511
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/19/2019

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 Catalogue Number: 2101-0200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 11/19/2019
• 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