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

Catalog Number 121725500

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Loss of Range of Motion (2032); Distress (2329); Deformity/ Disfigurement (2360); Limited Mobility Of The Implanted Joint (2671); No Information (3190)

Event Date 10/01/2012

Event Type  Injury  

Event Description

New etq record created in order to update etq (legacy system) complaint number wpc (b)(4).Reason for original complaint.Patient was revised to address a vertically.Malpositioned cup, with clunking and subluxation.Doi (b)(6) 2006 - dor (b)(6) 2012 (left hip).Update: (b)(4) 2013, pfs was received from legal, medical records were received from legal.There is no new information that would change the existing mdr decision.Records are available for further review.(b)(4) 2014 - x-rays received.X-rays may pertain to (b)(4).Update rec'd: (b)(4) 2014 - medical records received.Part/lot included.After review of the revision operative note it indicated metallosis so the liner and head are being reported.It also noted leg-length discrepancy so the stem and sleeve are being reported.There is no new additional information that would affect the existing mdr decision.The complaint was updated on: 3/10/2014.

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

No device associated with this report was received for examination.A complaint database search did find additional related reports against the metal liner and/or femoral head product code and lot number combination(s).However; a review of the device history record(s) associated with this complaint was not required per wi-3430.A worldwide complaint database search found no additional related reports against the remaining product code/lot code combination(s).Corrective action was not 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.

Event Description

Litigation alleges friction and wear between the cobalt-chromium of the head and liner that caused large amounts of toxic metal ions and particles released into the blood, tissue and bone resulting to emotional distress, disfigurement, loss of mobility and loss of range of motion.

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.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.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.Per nr-0134037 a medical record review is not required for this complaint record.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Device history lot : null.Device history batch : null.Device history review : null.

• 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: 3669693
• MDR Text Key: 4344533
• Report Number: 1818910-2014-13941
• 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
• Report Date: 02/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121725500
• Device Lot Number: AB3B14000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2019
• 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: 82