MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX25MM; HIP OTHER IMPLANT: SCREW

Catalog Number 121725500

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Discomfort (2330); Injury (2348); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 01/18/2012

Event Type  Injury  

Event Description

New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint.- litigation alleges that patient was revised due to pain with loosening and femoral component subsidence.Update: (b)(6) 2012 - pfs was received from legal, medical records were received from legal, and part/lot information was identified.Records are available for further review.Patient demographics added.Update rec'd (b)(6) 2014 - pfs and medical records received.After review of the medical records the revision operative note indicated pain, stem loosening, and subsidence of the stem.The cup, liner, femoral head, and screw are being reported as they cannot be excluded as the cause of pain.There is no new additional information that would affect the existing mdr decision.The complaint was updated on: (b)(6) 2014.

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.Udi: (b)(4).

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.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.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

Depuy still considers this investigation closed at this time.

Event Description

Update rec'd 1/25/2016: litigation papers.In addition to what has already been alleged, the litigation also alleges discomfort and corrosion/friction causing increased metal ions and metal debris.The previous review of the medical records indicated the revision operative note didn't indicate any corrosion or metal debris.No labs were provided for the alleged high metal ions.It should be noted that the patient had a poly on ceramic construct.This complaint was updated on: 1/28/2016.

Manufacturer Narrative

Examination of the reported devices was not possible as they were not returned.A search of the complaints databases found one other report against the d00450557 bone screw.Review of device history records finds no related manufacturing deviations or anomalies that would have contributed to the reported event.A search of the complaints databases identified no other reports against the remaining product/lot code combinations.Medical records were reviewed.The investigation can draw no conclusions with the information made available.Based on the inability to determine root cause, the need for corrective action has not been indicated.Monitor via sep-419.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.

Event Description

Ppf indicated that the patient had passed away, reason and date were not provided.

Manufacturer Narrative

Product complaint #: (b)(4).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

Litigation alleges limited mobility, difficulty in and around implant, and injury.Doi: (b)(6) 2011 - dor: (b)(6) 2012 (right hip).

Manufacturer Narrative

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

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.No code available (3191) was used to capture surgical intervention and medical device removal.

• Brand Name: PINN CAN BONE SCREW 6.5MMX25MM
• Type of Device: HIP OTHER IMPLANT: SCREW
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; suzhou industrial park; warsaw IN 46581 0988
• MDR Report Key: 4142155
• MDR Text Key: 4917056
• Report Number: 1818910-2014-29420
• Device Sequence Number: 1
• Product Code: NDJ
• Combination Product (y/n): N
• PMA/PMN Number: PK983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 121725500
• Device Lot Number: D00450557
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 66