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

Catalog Number	157012165
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994)
Date of Event	03/10/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
New unity record created in order to update legacy complaint number (b)(4).Patient was revised to address groin pain.The surgeon diagnosed alval.Doi: (b)(6) 2008 - dor: (b)(6) 2011 (right side).Update 2/28/2012 - litigation papers received.There is no new information that would change the outcome of the investigation.Medical records received.After review of medical records for the mdr reportability, patient had a tender lympnode in the groin, pain, elevated chromium and cobalt and seems to have aseptic lymphocytic vasculitis ulcerated lesions.Revision notes reported that the patient had pain and alval reaction.It was also indicated that a large amount of bursitic fluid has been evacuated and severe alval.Doi: (b)(6) 2008; dor: (b)(6) 2011.
Additional Manufacturer Narrative
(b)(4).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.The device manufacturing records have been reviewed for the femoral stem.No related deviations or anomalies were identified.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: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7117335
• Report Number: 1818910-2017-51684
• Device Sequence Number: 1272745
• Product Code: LPH
• UDI-Device Identifier: 10603295060208
• UDI-Public: 10603295060208
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 157012165
• Device Lot Number: BY7KS1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2017
• Supplement Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 02/27/2018
• 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: 59 YR