MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 18189 SUMMIT DUOFIX TAP SZ3 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number	157012090
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104); Test Result (2695)
Date of Event	08/13/2013
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.No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.
Event or Problem Description
Asr revision, asr xl - right, reason(s) for revision: pain and cobalt and chromium: metalosis.Update - marked as legal, added kid number, filed out mw fields and added a sleeve.Taken from (b)(6) update dated (b)(6) 2014.Additional information: please note this com has been re-opened to add cobalt and chromium: metalosis in the description.No action activity is needed as this revision reason was already added in the drop down complaint category previously so had already been reported.(b)(6).Update ad (b)(6) 2018: (b)(4) has been re-opened under (b)(4) because of a new alert received.There are no new or additional information indicated on this update.¿.
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.1818910-2018-64696-2 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 SZ3 HI OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 18189; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7698431
• Report Number: 1818910-2018-64696
• Device Sequence Number: 1076458
• Product Code: LPH
• UDI-Device Identifier: 10603295060147
• UDI-Public: 10603295060147
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2018

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: 157012090
• Device Lot Number: AL6AR1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 06/21/2018; 09/11/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 07/18/2018; 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1749/1816-2011
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention