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

Catalog Number 121730500

Device Problem Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Tissue Damage (2104); No Code Available (3191)

Event Date 03/02/2015

Event Type  Injury  

Event Description

Patient was revised to address pain and black staining of the tissues.

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

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

Event Description

Update rec'd 03/23/2015 - the patient's medical records were received.Medical records were reviewed for mdr reportability.According to the medical records the patient was revised to address increasing pain.Upon revision metallosis, black synovial tissue, and a cyst in the greater trochanter were found.Also noted, one of the screws in the acetabulum was prominent but there was no indication of wear on the backside of the liner, the screw was removed.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible for the unknown lot code(s).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.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

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

Update rec¿d 05/18/2016 - litigation papers received.In addition to what was previously reported, litigation also alleges the patient suffers from elevated metal ions, metal debris, and limited mobility.There is no new information that would change the existing mdr decision.Updated head/liner/screws and added stem.Complaint updated 06/03/2016.

Event Description

Update 3/31/2017 pfs and medical records received.After review of the medical records for mdr reportability, lab values were provided that confirmed elevated chromium level.The unknown screw is being rejected as only one screw implanted.

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 pseudotumor, abductor muscle repair and metal wear.Added lawyer and updated patient harm.Doi: (b)(6) 2005 - dor: (b)(6) 2015 (right hip).

Event Description

Complaint description: patient was revised to address pain and black staining of the tissues.Update rec¿d 03/23/2015 - the patient's medical records were received.Medical records were reviewed for mdr reportability.According to the medical records the patient was revised to address increasing pain.Upon revision metallosis, black synovial tissue, and a cyst in the greater trochanter were found.Also noted, one of the screws in the acetabulum was prominent but there was no indication of wear on the backside of the liner, the screw was removed.The complaint was updated on: 04/22/2015 update rec¿d 05/18/2016 - litigation papers received.In addition to what was previously reported, litigation also alleges the patient suffers from elevated metal ions, metal debris, and limited mobility.There is no new information that would change the existing mdr decision.Updated head/liner/screws and added stem.Complaint updated 06/03/2016 update 3/31/2017 pfs and medical records received.After review of the medical records for mdr reportability, lab values were provided that confirmed elevated chromium level.The unknown screw is being rejected as only one screw implanted.Complaint updated 04/18/2017.: / | investigation method: a cd containing ap and lateral radiographs of the right hip dated 27 aug 2014 were reviewed 3 nov 2015 per wi-7915.There was no evidence of implant fracture or implant disassociation.See attached x-ray review form.----------------- no device associated with this report was received for examination.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(s).Based on the inability to find any additional related reports against the provided product code/lot code combination(s) 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.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible for the unknown lot code(s).The reported event is considered one of the possible complications of joint replacement.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.------ the patient is considered obese.It is stated in the warnings and precautions that excessive patient weight tends to adversely affect hip replacement implants.A search of the complaints databases identified other reports againt the metal femoral head and no others against the remaining product/lot code combinations.A search of the complaints databases and/or review of the screw device history records was not possible as the necessary product/lot code combination was not provided.No device(s) associated with this report was received for examination.No further changes to previous investigation / | investigation summary: patient was revised to address pain and black staining of the tissues.Update rec¿d 03/23/2015 - the patient's medical records were received.Medical records were reviewed for mdr reportability.According to the medical records the patient was revised to address increasing pain.Upon revision metallosis, black synovial tissue, and a cyst in the greater trochanter were found.Also noted, one of the screws in the acetabulum was prominent but there was no indication of wear on the backside of the liner, the screw was removed.No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible for the unknown lot code(s).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.Update rec¿d 05/18/2016 - litigation papers received.In addition to what was previously reported, litigation also alleges the patient suffers from elevated metal ions, metal debris, and limited mobility.There is no new information that would change the existing mdr decision.Updated head/liner/screws and added stem.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.

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.  h10 additional narrative:  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.

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.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.No device associated with this report was received for examination.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.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.Per internal procedures, the event information and any investigational inputs received as part of required follow up were reviewed.For this investigation, no immediate action was required as no alleged deficiency with the device(s) was identified.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.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.

• 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: 4610041
• MDR Text Key: 5695934
• Report Number: 1818910-2015-16317
• Device Sequence Number: 1
• Product Code: NDJ
• Combination Product (y/n): N
• PMA/PMN Number: K983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor,distributor,health prof
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2009
• Device Catalogue Number: 121730500
• Device Lot Number: YS5JG1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 109