MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ2 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number	157011080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Injury (2348); Test Result (2695); Not Applicable (3189)
Date of Event	03/11/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Additional 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
Litigation papers allege the following: two weeks following surgery, patient's hip spontaneously dislocated while she was laying quietly, 911 was called and patient was taken to the emergency room.After relocating the pinnacle hip, patient was placed in a restraining brace which left her essentially bedridden for the next two months.However, in the months after surgery, patient continued having increasing pain in her hip.In (b)(6) 2011 patient was diagnosed with "inflammatory synovitis from metal" and tested for and diagnosed with elevated metal levels.Due to the pain associated with her pinnacle hip, patient was no longer able to stand for any period of time, was no longer able to carry out her duties as a registered nurse working with babies in the newborn intensive care unit.This resulted in the loss of the professional position she had held for the past 23 years.Patient has suffered from injuries of a permanent, lasting and painful nature.Furthermore, patient's ability to perform normal and enjoy regular activities has been impaired.Doi: (b)(6) 2009 - no revision reported at this time.(right side).Update 24 apr 2018: (b)(4) has been re-opened under (b)(4) due to receipt of ppf and sticker sheets received.Ppf alleges dislocation.Added stem due to previously alleged elevated metal ions.Doi: (b)(6) 2009, dor: (b)(6) 2011 (right hip).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision depuy synthes of 21 cfr, part 803.This report may be based on 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.Additional 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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SUMMIT POR TAPER SZ2 HI OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7812380
• Report Number: 1818910-2018-67584
• Device Sequence Number: 19246704
• Product Code: JDI
• UDI-Device Identifier: 10603295060031
• UDI-Public: 10603295060031
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2018
• Device Catalogue Number: 157011080
• Device Lot Number: C52FN1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 12/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR