MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT POR TAPER SZ5 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number 157011110

Device Problem Biocompatibility (2886)

Patient Problems Pain (1994); Test Result (2695); No Code Available (3191)

Event Date 07/08/2014

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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.Initial reporter occupation: non-healthcare professional "attorney".(b)(4).

Event Description

Complaint description: patient has been revised address pain.Update ad 17 aug 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and implant records.In addition to what was previously alleged.Ppf alleges elevated metal ions.Added lawyer, law firm, account name and stem due to alleged elevated metal ions.Doi: (b)(6) 2007 - dor: (b)(6) 2014, (left hip).

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.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: b18e11.Device history batch: null.Device history review: 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 POR TAPER SZ5 HI OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 8619284
• MDR Text Key: 145356888
• Report Number: 1818910-2019-93772
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295060062
• UDI-Public: 10603295060062
• Combination Product (y/n): N
• PMA/PMN Number: K001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 157011110
• Device Lot Number: B18E11000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR