MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT POR TAPER SZ7 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-01-135

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Injury (2348); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 08/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Der states that the patient had hip replaced about 14 years ago.They started having groin pain that consistently worsened.Doctor went in and took out metal liner and metal head and put in a ceramic on poly.Update 30 nov 2018.Pinnacle litigation records received.Litigation alleges that the friction and wear between the cobalt-chromium metal head and cobalt-chromium metal liner caused toxic cobalt-chromium metal ions and particles to be released into the plaintiff's blood and tissue, and bone surrounding the implants.It is further alleged that the patient experienced severe pain, discomfort, inflammation in and around the implant, injury, partial or complete loss of mobility, loss of range of motion and suffering.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4) used to capture the patient code metal poisoning.

Event Description

Pfs alleges injuries, pain, physical limitations, elevated metal ion levels.Medical records received.After review of medical records, the patient was revised to address metallosis and pain.Laboratory workout showed elevated cobalt and chromium levels.However, the actual values were below 7 ng/ml.A visit to the doctor on (b)(6) 2017 indicated bursitis, toxic effect of metal and foot drop.Doi: (b)(6) 2004 - dor: (b)(6) 2017; (right hip).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.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.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

Product complaint # (b)(4).Investigation summary: investigative update: (b)(6) 2021.Medical records including x-ray images have been provided for review.No device associated with this report was received for examination.Provided x-rays have been reviewed.Nothing indicative of a product problem is identified.Most images are post revision of the metal on metal articulating construct that is subject of this complaint.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.There is otherwise no additional information and no change is required to the initial investigative results.No evidence was found indicating product error was a contributing factor.The need for corrective action was not indicated.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Corrected: g1.

• Brand Name: SUMMIT POR TAPER SZ7 STD OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8200085
• MDR Text Key: 131520842
• Report Number: 1818910-2018-79219
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295059387
• UDI-Public: 10603295059387
• Combination Product (y/n): N
• PMA/PMN Number: K001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/30/2018

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 Model Number: 1570-01-135
• Device Catalogue Number: 157001135
• Device Lot Number: YH7B31000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 08/05/2019; 12/30/2019; 05/12/2021
• Supplement Dates FDA Received: 08/23/2019; 12/31/2019; 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 91