MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 12/14 ARTICUL 40MM M SPEC+1.5; HIP FEMORAL HEAD

Catalog Number 136505000

Device Problems Metal Shedding Debris (1804); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Erosion (1750); Unspecified Infection (1930); Inflammation (1932); Irritation (1941); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Discomfort (2330); Injury (2348); Osteolysis (2377); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189); No Code Available (3191)

Event Date 10/17/2017

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.It was also indicated that hypertrophic tissue excised and normal cocr levels.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible for the unknown lot code(s).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.Depuy considers the investigation closed at this time.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

Pinnacle litigation record received.In addition to what was previously reported, litigation alleges friction and wear between the cobalt-chromium metal head and metal liner that caused large amounts of toxic cobalt-chromium metal ions,severe pain, discomfort and inflammation in and around his implant.Doi: (b)(6) 2011; dor: (b)(6) 2017; left hip.

Event Description

Pfs and medical records received.Pfs alleges pain, physical injuries, decreased range of motion and mobility, elevated metal ions, inflammation, tissue damage caused by metal debris, unable to do normal activities, difficulty with stairs, walks with slight limp, cannot sit extended time and bend more than 90 degrees.After review of medical records for mdr reportability, patient was revised to address left hip adverse tissue reaction secondary to modular metal on metal total hip arthroplasty.Revision notes stated that there was erosion through the abductor and iliotibial band and markedly thickened capsule which was reactive and hypertrophic.Clinical visit reported pain, limb length discrepancy (left leg 1cm longer than the right leg),and discomfort.Mri showed marked soft tissue thickening.Radiographs showed some osteolysis at the neck region.Lab result shows metal ion levels above 7ppb.

Event Description

Plaintiff fact sheet received.Pfs alleges pain, physical injuries, decreased range of motion and mobility, elevated metal ions, inflammation,infection (left hip), tissue damage caused by metal debris,unable to do normal activities, difficulty with stairs, walks with slight limp, cannot sit extended time and bend more than 90 degrees.

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.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, 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).

Event Description

Ppf alleges metallosis.

• Brand Name: 12/14 ARTICUL 40MM M SPEC+1.5
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 7032805
• MDR Text Key: 92056122
• Report Number: 1818910-2017-28975
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295032960
• UDI-Public: 10603295032960
• Combination Product (y/n): N
• PMA/PMN Number: K060031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/17/2017

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: 04/12/2016
• Device Catalogue Number: 136505000
• Device Lot Number: 3291114
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/17/2017
• Initial Date FDA Received: 11/15/2017
• Supplement Dates Manufacturer Received: 12/13/2017; 02/20/2018; 04/10/2018; 04/12/2018; 04/10/2019; 11/28/2019
• Supplement Dates FDA Received: 12/13/2017; 02/26/2018; 04/17/2018; 04/26/2018; 05/03/2019; 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 109