MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 NEUT 36IDX62OD; HIP ACETABULAR INSERT/LINER

Catalog Number 122136462

Device Problem Insufficient Information (3190)

Patient Problems Cellulitis (1768); Erythema (1840); Unspecified Infection (1930); Pain (1994); Seroma (2069); Skin Irritation (2076)

Event Date 06/20/2016

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

Patient was revised to address a skin/wound infection (cellulitis).

Manufacturer Narrative

Additional narrative: 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 - 7/25/16 pfs and medical records received.After review of the medical records for mdr reportability, there is no new additional information that would affect the existing investigation.

Manufacturer Narrative

Patient was revised to address a skin/wound infection (cellulitis) update 7/25/16- disc 342 pfs and medical records received.There is no new additional information that would affect the existing mdr decision.Examination of the reported devices was not possible as they were not returned.A search of the complaints databases finds no other reports against the product and lot code combinations since their release to distribution.The investigation can draw no conclusion 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.Should additional information be received the investigation will be reopened.

Event Description

Update sep 12, 2017: legal medical records.After review of the medical records for the mdr reportability, in addition to what was previously reported, revision notes reported of large seroma which did not appear infected, and no frank puss.Microbiology reported negative for infection.Clinical notes reported increasing pain, erythema, tenderness and a large fluid collection which had the gross appearance of a seroma.This complaint was updated on oct 2, 2017.

Manufacturer Narrative

Udi: (b)(4).

Manufacturer Narrative

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

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.

Event Description

Complaint description: patient was revised to address a skin/wound infection (cellulitis) update - 7/25/16 pfs and medical records received.After review of the medical records for mdr reportability, there is no new additional information that would affect the existing investigation.The complaint was updated on: 08/17/2016.Update sep 12, 2017: legal medical records.After review of the medical records for the mdr reportability, in addition to what was previously reported, revision notes reported of large seroma which did not appear infected, and no frank puss.Microbiology reported negative for infection.Clinical notes reported increasing pain, erythema, tenderness and a large fluid collection which had the gross appearance of a seroma.This complaint was updated on oct 2, 2017.

• Brand Name: ALTRX +4 NEUT 36IDX62OD
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 5801980
• MDR Text Key: 49759797
• Report Number: 1818910-2016-23352
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K062148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/20/2016

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: 11/30/2018
• Device Catalogue Number: 122136462
• Device Lot Number: 461437
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/20/2016
• Initial Date FDA Received: 07/18/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 09/12/2017; 08/13/2018; 11/19/2018; 11/26/2018
• Supplement Dates FDA Received: 08/18/2016; 08/22/2016; 10/04/2017; 08/13/2018; 11/20/2018; 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 101