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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	07/07/2015
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.Device was used for treatment, not diagnosis.
Event or Problem Description
Ppf received.Ppf alleged elevated metal ions.The metal liner, metal head, and the stem were reported to the impacted product due to the ppf allegation.Doi: (b)(6) 2009; dor: (b)(6) 2015; (right hip).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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: 8416557
• Report Number: 1818910-2019-87173
• Device Sequence Number: 19207732
• Product Code: LPH
• UDI-Device Identifier: 10603295060192
• UDI-Public: 10603295060192
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2019

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: DE8DB1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 04/10/2019
• 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: Other
• Patient Age: 59 YR