MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT DUOFIX TAP SZ8 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number	157012150
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Hypoesthesia (2352); Test Result (2695)
Date of Event	08/31/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 etq record created in order to update etq (legacy system) complaint number wpc (b)(4).Reason for original complaint.- litigation papers allege the patient began experiencing pain and tenderness in her right hip and groin.Additionally it is alleged the patient has suffered from severe pain, numbness, inability to sleep normally, and faces possible metal poisoning, bone loss, chronic pain, a decrease in his quality of life and other serious medical problems.Update: (b)(6) 2012 pfs was received from legal, medical records were received from legal, and part/lot information was identified.Records are available for further review.Doi: (b)(6) 2005, dor: none reported, (right hip).Doi:(b)(6) 2005, dor: non reported, (left hip).
Additional Manufacturer Narrative
(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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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 SZ8 HI OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7628648
• Report Number: 1818910-2018-62891
• Device Sequence Number: 13921244
• Product Code: LPH
• UDI-Device Identifier: 10603295060192
• UDI-Public: 10603295060192
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 157012150
• Device Lot Number: Y79FL1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 06/17/2018; 06/17/2019
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 06/20/2019; 06/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR