MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX30MM; HIP OTHER IMPLANT

Catalog Number 121730500

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

Patient Problems Host-Tissue Reaction (1297); No Information (3190)

Event Date 02/14/2013

Event Type  Injury  

Event Description

Litigation alleges that the patient suffers from pain, discomfort, inflammation, difficulty ambulating, clicking/clanking noises, and elevated levels of metal ions.Update: (b)(4) 2013 - pfs and medical records received.Part/lot was provided.The actual dor was provided.There is no new additional information that would affect the existing mdr decision.Update rec'd (b)(4) 2013 - pfs and medical records received.Part/lot info given.After review of the medical records/operative notes it indicated metal debris, impingment between the stem and cup, cup anteversion, corrosion, stem anteversion, and leg length discrepancy.The stem, cup, and a screw are being added to this complaint.There is no new additional information that would affect the existing mdr decision.The complaint was updated on: 05/28/2014.

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.(b)(4).

Manufacturer Narrative

No device associated with this report was received for examination.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.Medical records were obtained and reviewed by a medical professional.From a medical perspective, based on the information available, it is unlikely the complaint is product related.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 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.Udi: (b)(4).

Event Description

Ppf alleges metallosis.After review of medical records, patient was revised to address metal debris, impingement of the femoral neck and anteversion of stem and cup.Revision notes reported metal gray debris in the trochanteric bursa and impingement of the metal cup.

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 6.5MMX30MM
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 3837099
• MDR Text Key: 4620702
• Report Number: 1818910-2014-19681
• 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: 05/03/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121730500
• Device Lot Number: C56FC4000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 73