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

Catalog Number 121725500

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Inflammation (1932); Pain (1994); Discomfort (2330); Osteolysis (2377); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671)

Event Date 02/06/2013

Event Type  Injury  

Event Description

Litigation alleges pain, discomfort, inflammation, popping and snapping sensations and elevated metal ion levels.Update rec¿d (b)(6) 2014 - pfs was received from legal, primary and revision medical records were received from legal, and part/lot information was identified.Records indicate that the patient was revised because of pain, osteolysis, and loose cup.Records are available for further review.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.

Manufacturer Narrative

The devices associated with this report were not returned.A complaint database search found one additional complaint against the 2513402 lot code.Per wi-3430, revision c, a review of the device history records is no longer required for this product.A complaint database search finds no other reported incidents against the remaining product and lot combinations.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.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 metal wear/metallosis and elevated metal ions.The stem was added to ip due to elevated metal ions and also added the hole eliminator to ip that would have also been removed along with the cup.Updated patient harm and added associated contact and law firm in the facility name.

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: PINN CAN BONE SCREW 6.5MMX25MM
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 3798983
• MDR Text Key: 4381925
• Report Number: 1818910-2014-18320
• 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,consumer,other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/08/2014

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: 04/16/2013
• Device Catalogue Number: 121725500
• Device Lot Number: B53BL4000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/15/2015
• Initial Date FDA Received: 05/08/2014
• Supplement Dates Manufacturer Received: Not provided; 09/17/2018; 12/31/2019
• Supplement Dates FDA Received: 06/17/2015; 09/19/2018; 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 102