MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. PINN CAN BONE SCREW 6.5MMX35MM; HIP OTHER IMPLANT: SCREW

Catalog Number 121735500

Device Problems Metal Shedding Debris (1804); Malposition of Device (2616); Difficult to Advance (2920); Appropriate Term/Code Not Available (3191)

Patient Problems Pulmonary Embolism (1498); No Information (3190)

Event Date 01/14/2013

Event Type  Injury  

Event Description

Patient was revised to address a reaction to metal.Update rec'd 10/1/2014 - litigation papers received.In addition to what was previously reported, litigation alleges the patient suffers from pain, a squeaking noise, a clicking sensation, osteolysis, a distal femur fracture, a fracture of the greater trochanter, lucency within the right ischium including the posterior column of the acetabulum, a large soft tissue lesion lateral to her right hip, a large fluid collection lateral to her right hip, a reactive pseudomass, bursitis, a cystic metal-tinged reactive mass in the right adnexa, metallosis, elevated metal ion levels, and a cystic metal-stained reactive debris found in the anterior capsule and inferior capsule.There is no new additional information that would affect the outcome of the investigation.Update 11/26/2014- pfs and medical records received.After review of the medical records for mdr reportability, the revision operative note indicated osteolysis, pathologic greater trochanter fracture that is healing, metallosis, metal debris around the screw, reactive soft tissue mass, corrosion on the trunnion, , threading at the screw/cup interface, and the screw was proud and had a deformation at the head.The stem is being added for the alleged high metal ions (no lab results provided).There was no mention of a loose cup as previously mentioned.There is no new additional information that would affect the existing mdr decision.The complaint was updated on: 12/23/2014.

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.(b)(4).

Manufacturer Narrative

Examination of the reported devices was not possible as they were not returned.Additional medical records were received but not reviewed per nc ((b)(4)).Previous review of provided patient x-rays reveals stem slightly in varus position.Cup inclination was difficult to review due to the implant position, without the implant it is not possible to confirm if this lead to increased wear of the device.A complaint database search finds no other reported incidents against the provided product and lot combinations since their release for distribution.The investigation can draw no conclusions with the information provided.Based on the inability to determine a root cause, the need for corrective action has not been identified.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

Examination of the reported devices was not possible as they were not returned.Additional medical records were received and reviewed.Previous review of provided patient x-rays reveals stem slightly in varus position.Cup inclination was difficult to review due to the implant position, without the implant it is not possible to confirm if this lead to increased wear of the device.A complaint database search finds no other reported incidents against the provided product and lot combinations since their release for distribution.The investigation can draw no conclusions with the information provided.Based on the inability to determine a root cause, the need for corrective action has not been identified.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

(b)(4).

Event Description

In addition to what were previously alleged, ppf alleges pseudotumor, pulmonary embolism, dislocation, metal wear and metallosis.Added law firm, surgeon, account name and product details in ips.Doi: (b)(6) 2002; dor: (b)(6) 2013 (right hip).

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.Product complaint # (b)(4).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: PINN CAN BONE SCREW 6.5MMX35MM
• Type of Device: HIP OTHER IMPLANT: SCREW
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 4358115
• MDR Text Key: 5203750
• Report Number: 1818910-2014-35070
• 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: Health Professional,Distributor,consumer,distributor,he
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 121735500
• Device Lot Number: V64EK1183
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 81