MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 SUMMIT DUOFIX TAP SZ9 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number	157012165
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Test Result (2695)
Date of Event	01/01/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).That was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Litigation alleges that the patient is required to live with pain, crunching, limping, popping, elevated levels of metal ions in his blood and continues to require ongoing medical care for both hips.Doi: (b)(6) 2007 right hip dor: none reported.Doi: (b)(6) 2008 left hip dor: none reported.Patient is bilateral.Patient is a resident of (b)(6).Update - (b)(6) 2013 - plaintiff's preliminary disclosure form was received, which identified part/lot information.The complaint and associated mdrs were updated.There was no new information that would change the outcome of the investigation.This pc is for the left hip.See (b)(4) for the right hip.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SUMMIT DUOFIX TAP SZ9 HI OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7374090
• Report Number: 1818910-2018-56215
• Device Sequence Number: 1067973
• Product Code: LPH
• UDI-Device Identifier: 10603295060208
• UDI-Public: 10603295060208
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/17/2011
• Device Catalogue Number: 157012165
• Device Lot Number: AJ5EE1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2018
• Supplement Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 10/03/2018
• 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: Required Intervention
• Patient Age: 65 YR