MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX56OD; HIP ACETABULAR INSERT/LINER

Catalog Number 121887456

Device Problems Device Slipped (1584); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Inflammation (1932); Pain (1994); Discomfort (2330); Joint Disorder (2373); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 10/12/2016

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

Patient was revised due to pain and possible cup loosening.

Manufacturer Narrative

Examination of the reported devices was not possible as they were not returned.A search of the complaints databases identified other reports against the liner.Per procedure, this device is exempt from device history record review.A search of the complaints databases identified no other reports against the remaining product/lot code combinations.X-rays 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.Should additional information be received the investigation will be reopened.

Event Description

Update rec'd 11/03/2016 - the patient's medical records were received.Medical records were reviewed for mdr reportability.According to the medical records, upon revision the patient's acetabular shell was found to be slightly prominent but was not loose.At this time there is no new information that would change the existing mdr decision.

Manufacturer 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 rec¿d 12/19/2016- litigation papers received.Litigation alleges pain and general litigation notes metal on metal implications.

Manufacturer Narrative

Examination of the reported devices was not possible as they were not returned.A search of the complaints databases identified other reports against the liner.Per procedure, this device is exempt from device history record review.A search of the complaints databases identified no other reports against the remaining product/lot code combinations.X-rays 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 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.

Event Description

Pfs alleges pain, soreness, discomfort, limited mobility and instability.After review of medical records, pathology result reported mild chronic inflammation and fine granular pigment deposition.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision depuy synthes 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: 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, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINNACLE MTL INS NEUT40IDX56OD
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 6059109
• MDR Text Key: 58452132
• Report Number: 1818910-2016-30089
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K062426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2013
• Device Catalogue Number: 121887456
• Device Lot Number: 2755714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 108