MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ4 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number 157002100

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Weakness (2145); Test Result (2695); No Code Available (3191)

Event Date 11/04/2014

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.Occupation: attorney.(b)(4).

Event Description

Complaint description: patient was revised to address pain and cup malpositioning.Update rec'd 9/17/15 - litigation papers received.In addition to what was previously reported, litigation alleges the patient suffers from weakness.Update 1/31/17- pfs and medical records received.After review of the medical records for mdr reportability, the revision operative note indicated pain, malpositioned cup (50 degrees abduction), normal cobalt/chromium levels, and dislocations/subluxations.Update ad 01 apr 2019: receipt of ppf and sticker sheets record.In addition to what were previously alleged, ppf allege elevated metal ions.

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 SZ4 STD OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8539384
• MDR Text Key: 142736314
• Report Number: 1818910-2019-91277
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295059455
• UDI-Public: 10603295059455
• Combination Product (y/n): N
• PMA/PMN Number: K011489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 157002100
• Device Lot Number: B36C71000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 104