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

Model Number 1570-01-150

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

Patient Problems Erosion (1750); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Tissue Damage (2104); Distress (2329); Injury (2348); Test Result (2695); Not Applicable (3189); No Code Available (3191)

Event Date 12/28/2017

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

New unity record created in order to update legacy complaint  (b)(4).Litigation alleges that patient has experienced pain and has tested positive for elevated levels of cobalt and chromium in his blood.Doi: (b)(6) 2008 - dor: none reported (right hip).**patient is a resident of (b)(6).Update 30 mar 2018 asr litigation received.In addition to what were previously alleged, litigation alleges injuries, loosening, metal reaction, suffering and emotional distress.Doi: (b)(6) 2008 ; dor: (b)(6) 2017; right hip.This complaint was updated on: apr 04, 2018.

Manufacturer Narrative

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

Manufacturer Narrative

Product complaint #
=
> pc-(b)(4).

Event Description

Asr xl's pfs and medical record received.Pfs has no new allegations reported.After review of medical records for the mdr reportability, patient was revised to address metallosis.Operative note reported erosion of the anterior acetabulum and the inflammatory tissue was debrided.

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.No device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Per internal procedures, the event information and any investigational inputs received as part of required follow up were reviewed.For this investigation, no immediate action was required as no alleged deficiency with the device(s) was identified.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.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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.H10 additional narrative: e3 initial reporter occupation: lawyer.H6 patient code: no code available (3191) was used to capture surgical intervention and emotional distress 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.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5, d10 and h6 (patient).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer 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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SUMMIT POR TAPER SZ8 STD OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC., 1818910; 700 orthopaedic drive; depuy international ltd - 8010; warsaw IN 46581 0988
• MDR Report Key: 7464179
• MDR Text Key: 106595442
• Report Number: 1818910-2018-58301
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295059394
• UDI-Public: 10603295059394
• 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: 03/30/2018

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 Expiration Date: 07/19/2018
• Device Model Number: 1570-01-150
• Device Catalogue Number: 157001150
• Device Lot Number: C13FB1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/30/2018
• Initial Date FDA Received: 04/26/2018
• Supplement Dates Manufacturer Received: 05/02/2018; 07/12/2018; 04/07/2020; 05/06/2020; 02/10/2021; 02/25/2021
• Supplement Dates FDA Received: 05/08/2018; 07/17/2018; 04/16/2020; 05/06/2020; 02/18/2021; 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVES 12/14 +5; ASR ACETABULAR CUPS 60; ASR UNI FEMORAL IMPL SIZE 53
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR