MAUDE Adverse Event Report: ORTHO DEVELOPMENT ALPINE; BIPOLAR HIP

Model Number	700-0014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the information provided, it does not appear that the revision was due to any device related failure.Issue appears to be related to surgeon's size selection.
Event or Problem Description
A patient underwent cementless bipolar surgery on (b)(6) 2016.The surgeon noted subsidence in a post-op visit and decided to continue to monitor.On (b)(6) 2017, the patient was revised with a bipolar stem from a different manufacturer.The surgeon suspected the subsidence was caused by selecting a stem size that was too small.

• Brand Name: ALPINE
• Common Device Name: BIPOLAR HIP
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• MDR Report Key: 7283660
• Report Number: 1722511-2018-00002
• Device Sequence Number: 11105749
• Product Code: KWY
• UDI-Device Identifier: 00822409000067
• UDI-Public: (01)00822409000067(17)210208(10)A160736
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2018

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: 02/08/2021
• Device Model Number: 700-0014
• Device Lot Number: A160736
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2017
• Initial Report FDA Received Date: 02/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1