MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 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 Adhesion(s) (1695); Foreign Body Reaction (1868); Hearing Impairment (1881); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Rash (2033); Scar Tissue (2060); Discomfort (2330); Hypoesthesia (2352); Joint Disorder (2373); Numbness (2415); No Code Available (3191)

Event Date 01/29/2015

Event Type  Injury  

Manufacturer Narrative

This report is still under investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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, metallosis, pain, discomfort, and inflammation.

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.Revision surgical report noted the patient with increased ions, no metallosis, a more vertical cup position and the liner was stuck in the cup and on attempt to remove the liner, the entire cup and liner came out together.There were no lab results.The cup will be added to complaint for malposition and loosening.Part/lot updated.The complaint was updated on: feb 25, 2016.

Manufacturer Narrative

Additional narrative: examination of the reported devices was not possible as they were not returned.A search of the complaints databases identified no other related reports against the product/lot code combinations.Medical records were reviewed.The investigation can draw no conclusions with the information provided.Based on the inability to determine root cause, the need for corrective action has not been 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 04/11/2016 - 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.Pathology report from revision surgery reported femoral head and taper had fretting corrosion, harms updated.There was no report of corrosion on the stem.Medical records also reported hip stiffness, range of motion difficulty and instability.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.Litigation has no new allegations.After review of the medical records for the mdr reportability, patient was revised due to failed right hip replacement secondary to metal on metal with increased ions and pain.It was stated in the operative indication that the right hip had a more vertical position cup.Revision notes stated that there were no signs of any frank metallosis and very little joint fluid in the joint itself.The trunnion and stem was found to be in good condition and stable.Attempts were made to remove the metal liner and it was found to be ceased to the cup.The frozen section of the scar tissue came back negative for acute inflammation.Surgical pathology report stated that the posterior capsule biopsy had partially necrotic fibrous membrane with mild chronic inflammation.Laboratory results for cobalt are above 7ppb.This complaint was updated on jun 26, 2017.

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.  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

Complaint description: litigation alleges patient suffers from toxic cobalt chromium metal ions, metalosis, pain, and discomfort.Update 2/1/2016: 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.Revision surgical report noted the patient with increased ions, no metallosis, a more vertical cup position and the liner was stuck in the cup and on attempt to remove the liner, the entire cup and liner came out together.There were no lab results.The cup will be added to complaint for malposition and loosening.Part/lot updated.The complaint was updated on: feb 25, 2016.Update 4/11/2016: 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.Pathology report from revision surgery reported femoral head and taper had fretting corrosion, harms updated.There was no report of corrosion on the stem.Medical records also reported hip stiffness, range of motion difficulty and instability.There is no new additional information that would affect the existing investigation.The complaint was updated on: may 3, 2016.Update jun 13, 2017: legal medical records received.Litigation has no new allegations.After review of the medical records for the mdr reportability, patient was revised due to failed right hip replacement secondary to metal on metal with increased ions and pain.It was stated in the operative indication that the right hip had a more vertical position cup.Revision notes stated that there were no signs of any frank metallosis and very little joint fluid in the joint itself.The trunnion and stem was found to be in good condition and stable.Attempts were made to remove the metal liner and it was found to be ceased to the cup.The frozen section of the scar tissue came back negative for acute inflammation.Surgical pathology report stated that the posterior capsule biopsy had partially necrotic fibrous membrane with mild chronic inflammation.Laboratory results for cobalt are above 7ppb.This complaint was updated on jun 26, 2017.Investigation method: 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.The reported event is considered one of the possible complications of joint replacement.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.Medical records reviewed 28 mar 2016.With the information provided, it cannot be determined that the implants contributed to the reported events.Examination of the reported devices was not possible as they were not returned.A search of the complaints databases identified no other related reports against the product/lot code combinations.Based on the inability to find any other related incidents against the provided product and lot code combinations, it is not unreasonable to conclude that there are no anomalies with regard to manufacturing, inspection or sterilization contained in the device history records that would contribute to the reported event.The investigation can draw no conclusions with the information provided.Investigation summary: litigation alleges patient suffers from toxic cobalt chromium metal ions, metalosis, pain, and discomfort.Doi: on (b)(6) 2006, dor: on (b)(6) 2015, (right hip).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.Update 2/1/2016: 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.Revision surgical report noted the patient with increased ions, no metallosis, a more vertical cup position and the liner was stuck in the cup and on attempt to remove the liner, the entire cup and liner came out together.Examination of the reported devices was not possible as they were not returned.A search of the complaints databases identified no other related reports against the product/lot code combinations.Medical records were reviewed.The investigation can draw no conclusions with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.

• Brand Name: SUMMIT DUOFIX TAP SZ8 HI OFF
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 5068200
• MDR Text Key: 25418352
• Report Number: 1818910-2015-30258
• 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: Initial,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 Expiration Date: 01/23/2011
• Device Catalogue Number: 157012150
• Device Lot Number: AC5FC1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2015
• Initial Date FDA Received: 09/10/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 06/08/2018; 09/30/2019
• Supplement Dates FDA Received: 03/02/2016; 03/30/2016; 05/03/2016; 06/27/2017; 06/12/2018; 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 100