MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US APEX HOLE ELIM POSITIVE STOP; PINNACLE HIP SYSTEM : HIP ACETABULAR AUGMENT

Catalog Number 124603000

Device Problems Device Damaged Prior to Use (2284); Appropriate Term/Code Not Available (3191)

Patient Problems Not Applicable (3189); No Information (3190)

Event Date 11/18/2014

Event Type  Injury  

Event Description

Litigation alleges patient suffers from fluid, bone loss, pseudotumor, and pain.Update (b)(6) 2015 - pfs and medical records received.Pfs now alleges high metal ions.Lab results provided indicate the metal ion levels were below 7ppb.After review of the medical records for mdr reportability, the revision operative note indicated pain, swelling and pseudotumor.The revision operative note also indicated that while placing a "dome screw" it was noted to be stripped.It is believed the surgeon meant a hole eliminator, so an unknown depuy hole eliminator is being added to the complaint.Part/lot is being updated.The complaint was updated on: (b)(6) 2015.

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.Udi: unavailable.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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.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.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

(b)(4).

Event Description

Ppf alleges pseudotumor and elevated metal ions.The stem was added to the impacted product due to ppf alleges of elevated metal ions.The unknown hole eliminator was updated and added product code.Patient name was updated and added law firm in the facility name.

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.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.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: APEX HOLE ELIM POSITIVE STOP
• Type of Device: PINNACLE HIP SYSTEM : HIP ACETABULAR AUGMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 4851383
• MDR Text Key: 5810085
• Report Number: 1818910-2015-23836
• 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: Other,consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/24/2015

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 Catalogue Number: 124603000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/28/2015
• Initial Date FDA Received: 06/17/2015
• Supplement Dates Manufacturer Received: Not provided; 10/01/2018; 12/09/2019
• Supplement Dates FDA Received: 07/29/2015; 10/02/2018; 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 147