MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ5 STD OFF; HIP FEMORAL STEM/SLEEVE

Catalog Number 157002110

Device Problems Unstable (1667); Failure to Align (2522); Migration (4003)

Patient Problems Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330)

Event Date 05/21/2015

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Aug 15, 2017: litigation records received.Litigation alleges discomfort, pain, stiffness, loss of motion, elevated cobalt-chromium metal ions, loosening, metallosis, necrosis, and soft tissue damage.No part and lot information provided.Update 24 aug 2017: pfs and medical records received.In addition to what was previously alleged, pfs alleges misalignment, limp, poor balance, and instability.After review of medical records, it was reported that the patient was revised to address subsidence.Updated part and lot information.There was no metallosis or necrosis mentioned in the revision notes.There were no laboratory values provided for the alleged elevated metal ions.This complaint was updated on: aug 29, 2017.

Manufacturer Narrative

No device associated with this report was received for examination.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.

Manufacturer Narrative

(b)(4).

Event Description

In addition to what were previously alleged, ppf alleges loosening of cup and metal wear.

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.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.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 DUOFIX TAP SZ5 STD OFF
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 6864446
• MDR Text Key: 86106818
• Report Number: 1818910-2017-24585
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295059462
• UDI-Public: 10603295059462
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2023
• Device Catalogue Number: 157002110
• Device Lot Number: 411429
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 77