MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ8 HI OFF; HIP FEMORAL STEM/SLEEVE

Catalog Number 157012150

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body Reaction (1868); Hearing Impairment (1881); Pain (1994); Rash (2033); Discomfort (2330); Hypoesthesia (2352); Numbness (2415); No Code Available (3191)

Event Date 09/03/2015

Event Type  Injury  

Manufacturer Narrative

This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.

Event Description

Litigation alleges patient suffers from toxic cobalt chromium metal ions, pain, and discomfort.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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.Corrective action was not indicated.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.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).

Event Description

Update 2/1/16- pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Pfs reported metallosis, patient could not do daily tasks to run farm, numbness in feet, hearing and eyesight problems, rash on ankles, balance issues, and pain.There is still no revision reported for left hip.Part/lot updated.The complaint was updated on: feb 25, 2016.

Manufacturer Narrative

No device associated with this report was received for examination.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.Corrective action was not indicated.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.

Manufacturer Narrative

Depuy still considers this investigation closed at this time.

Event Description

Update 4/11/16- pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Lab results for metal ions were greater than 7 parts per billion and co-morbidities updated.There is no new additional information that would affect the existing investigation.The complaint was updated on: may 3, 2016.

Event Description

Update jun 13, 2017: legal medical records received.There are no new allegations.After review of medical records, there is no new information that changes the mdr reportability decision.Cobalt level taken on (b)(6) 2016 is above 7 mcg/l.Adding patient harm for the previously reported metallosis.This complaint was updated on jun 27, 2017.

Manufacturer Narrative

(b)(4).

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.  h10 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: 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.

Event Description

Ppf alleged elevated metal ions.Updated facility name.Doi: (b)(6) 2006.Dor: none reported (left hip).See (b)(4) for right hip.

Manufacturer Narrative

Product complaint #: (b)(4).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 caused or contributed to the potential event described in this report.Udi: (b)(4).

• Brand Name: SUMMIT DUOFIX TAP SZ8 HI OFF
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 5068417
• MDR Text Key: 25445222
• Report Number: 1818910-2015-30279
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK011489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Followup,Followup,Followup,Followup,Followup
• Report Date: 09/08/2015

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 Catalogue Number: 157012150
• Device Lot Number: Z86B41000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 12/27/2017; 06/08/2018; 01/15/2019
• Supplement Dates FDA Received: 03/02/2016; 03/29/2016; 05/03/2016; 06/28/2017; 01/15/2018; 06/12/2018; 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 100