MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN FEMORAL BROACH; HIP INSTRUMENT

Catalog Number UNK-HIP

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/21/2013

Event Type  Injury  

Event Description

Litigation alleges damage to the hip joint and body.Update rec'd (b)(4) 2014-pfs and medical records received.Part/lot information received.A dor was provided.After review of the medical records it was reviewed the patient was revised for a loose stem.The stem is now being added to the complaint.While implanting the new stem a fracture occurred in the stem during broaching and the fracture was cabled.An unknown broach is being added to the complaint.There is no new additional information that would affect the existing mdr decision.The complaint was updated on: (b)(4) 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.

Event Description

Pfs and medical records received.Part/lot information received.A dor was provided.After review of the medical records it was reviewed the patient was revised for a loose stem.The stem is now being added to the complaint.While implanting the new stem a fracture occurred in the bone during broaching and the fracture was cabled.An unknown broach is being added to the complaint.There is no new additional information that would affect the existing mdr decision.

Manufacturer Narrative

(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

Examination of the reported devices was not possible as they were not returned.A search of the complaints databases identified other reports against the femoral head and insert.Per procedure, this device(s) is exempt from device history record review.A search of the complaints databases identified no other reports against the remaining provided product/lot code combination.Medical records were reviewed.The investigation can draw no conclusions with the information provided.Based on the inability to determine root cause, the need for corrective action has not been 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

Ppf alleges elevated metal ions.

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.

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).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.A worldwide product / lot specific complaint database search, or device history record (dhr) review, was not possible because the required product code/lot code(s) was not provided.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.

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.H10 additional narrative: added:h6(device codes) product complaint # (b)(4).Investigation summary
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> 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN FEMORAL BROACH
• Type of Device: HIP INSTRUMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 3917289
• MDR Text Key: 4491073
• Report Number: 1818910-2014-22774
• Device Sequence Number: 1
• Product Code: HTQ
• Combination Product (y/n): N
• 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: 06/13/2014

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: Physician
• Device Catalogue Number: UNK-HIP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/13/2014
• Initial Date FDA Received: 07/07/2014
• Supplement Dates Manufacturer Received: Not provided; 08/20/2019; 01/04/2020; 03/12/2020
• Supplement Dates FDA Received: 05/13/2015; 08/23/2019; 01/06/2020; 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 102