MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. - 1818910 SUMMIT POR TAPER SZ8 HI OFF; HIP FEMORAL STEM/SLEEVE

Catalog Number 157011150

Device Problems Corroded (1131); Metal Shedding Debris (1804); Appropriate Term/Code Not Available (3191)

Patient Problems Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Discomfort (2330); Injury (2348); Joint Dislocation (2374); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189)

Event Date 02/22/2017

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

The patient was revised to address pain.Update aug 25, 2017: litigation received.In addition to what was previously reported, litigation alleges discomfort, soreness, limited ability to perform daily activities, friction and wear causing toxic metal ions.Added stem due to the alleged toxic metal ions.Added complainant information.This complaint was updated on sep 4, 2017.

Event Description

In addition to what was previously reported patient alleges worsening inflammation, limited mobility, elevated blood metal levels, pain and was completely unable to stand up straight or sleep.After the revision surgery the patient suffered recurrent dislocation.After review of medical records for mdr reportability it was reported that the patient was revised to address pain.Mri finding shows pseudotumor and fluid collection with elevated metal ion levels.Revision note stated, there was significant pseudotumor encountered and corrosion was noted just distal to the morse taper.There were no purulence or evidence of infection and there was no necrotic tissue.

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

Ppf, pfs, and medical records received.In addition to what was previously reported, ppf alleges injury, metal wear and metallosis confirmed.Pfs has no new allegations.After review of medical records, the patient was revised to address painful metal on metal hip.Laboratory findings from mri shows pseudotumor and fluid collection also with elevated ion levels.It also reported significant trunnionosis with corrosion just distal to the morse taper, pseudotumor, bloody fluid, no evidence of infection, no necrotic tissue, well fixed components.Doi: (b)(6) 2008; dor: (b)(6) 2017; 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.Product complaint # (b)(4).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 : 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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.Udi: (b)(4).

• Brand Name: SUMMIT POR TAPER SZ8 HI OFF
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. - 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6887514
• MDR Text Key: 87180625
• Report Number: 1818910-2017-25309
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295060093
• UDI-Public: 10603295060093
• Combination Product (y/n): N
• PMA/PMN Number: K001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/25/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2018
• Device Catalogue Number: 157011150
• Device Lot Number: CN6F71000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2017
• Initial Date FDA Received: 09/22/2017
• Supplement Dates Manufacturer Received: 03/29/2018; 04/18/2018; 03/07/2019; 11/26/2019
• Supplement Dates FDA Received: 04/11/2018; 05/18/2018; 03/19/2019; 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 100