MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 APEX HOLE ELIM POSITIVE STOP; HOLE ELIMINATOR

Catalog Number 124603000

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

Patient Problems Unspecified Infection (1930); Pain (1994); Skin Irritation (2076)

Event Date 12/24/2013

Event Type  Injury  

Event Description

Patient was revised to address infection.

Manufacturer Narrative

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

Manufacturer Narrative

The devices associated with this report were not returned.A complaint database search finds no other related incidents against the provided product and lot combinations.Additionally, research using the as400 system indicates that several pieces from the reported lots have been delivered, and, as no additional reports have been received, can be reasonably assumed implanted without issue.Requests for additional investigational inputs were made in accordance with (b)(4) appendix a.No additional information was obtained.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for 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

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Patient was revised to address infection.Doi: (b)(6) 2013 dor: (b)(6) 2013 (right hip).The devices associated with this report were not returned.A complaint database search finds no other related incidents against the provided product and lot combinations.Additionally, research using the as400 system indicates that several pieces from the reported lots have been delivered, and, as no additional reports have been received, can be reasonably assumed implanted without issue.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.No additional information was obtained.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Update rec'd 10/13/2014- pfs and medical records received.This complaint is now legal.Pfs alleges pain and not being able to perform daily activities.There was no mention of infection in the litigation, just two i&ds.The revision operative note indicated a deep infection, inflammation, and a residual pseudotumor that is reported in (b)(4).There is no new additional information that would affect the existing mdr decision.

Manufacturer Narrative

(b)(4).Added: (pro-code).

Event Description

Update 14 jul 2017: medical records received.After review of medical records, there is no new information added that changes the mdr decision.Added complainant information.Updated product information.This complaint was updated on: 07 aug 2017.

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
=
> 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: patient was revised to address infection.Update rec'd 10/13/2014- pfs and medical records received.This complaint is now legal.Pfs alleges pain and not being able to perform daily activities.There was no mention of infection in the litigation, just two i&ds.The revision operative note indicated a deep infection, inflammation, and a residual pseudotumor that is reported in (b)(4).There is no new additional information that would affect the existing mdr decision.The complaint was updated on: 11/6/2014.Update 14 jul 2017: medical records received.After review of medical records, there is no new information added that changes the mdr decision.Added complainant information.Updated product information.This complaint was updated on: 07 aug 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.  udi:(b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.

• Brand Name: APEX HOLE ELIM POSITIVE STOP
• Type of Device: HOLE ELIMINATOR
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; suzhou industrial park; warsaw IN 46581 0988
• MDR Report Key: 3563040
• MDR Text Key: 4054096
• Report Number: 1818910-2014-10372
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K963309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor,consumer,distributor,he
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/13/2014

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: 05/01/2023
• Device Catalogue Number: 124603000
• Device Lot Number: D13062410
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/29/2014
• Initial Date FDA Received: 01/08/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 07/14/2017; 05/03/2018; 02/28/2019; 02/10/2020
• Supplement Dates FDA Received: 04/30/2014; 11/06/2014; 02/13/2015; 08/09/2017; 05/16/2018; 03/07/2019; 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 100