MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 50MM; HIP ACETABULAR CUP

Catalog Number 121732050

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Edema (1820); Foreign Body Reaction (1868); Pain (1994); Skin Irritation (2076); Anxiety (2328); Discomfort (2330); Joint Swelling (2356); Depression (2361)

Event Date 02/02/2017

Event Type  Injury  

Manufacturer Narrative

Udi: unavailable.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.

Event Description

The litigation alleges the patient suffers from pain and discomfort.

Manufacturer Narrative

Examination of the reported devices was not possible as they were not returned.A search of the complaints databases and/or a review of device history records were not possible as the required product/lot code combinations were not provided.The investigation can draw no conclusion regarding the reported event with the information available.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.

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.

Event Description

Update 9/23/16-pfs and medical records received.After review of the medical records for mdr reportability, a correct doi was provided.Lab levels indicated the cobalt and chromium levels are above 7ppb.Part/lot is being updated.

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.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

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 03/15/2017 ¿pfs and medical records received.After review of the medical records for mdr reportability, in addition to what was previously reported, the medical records reported that the patient was revised to address breakage (fracture) of prosthetic joint, but the revision surgery notes reported that the patient was revised to address pain, discomfort, and some squeaking, significant effusion, the cup and stem were well fixed and there was no mention of a breakage (fracture) during the actual revision notes.The complaint was updated on: 04/05/2017.

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.Additional narrative: added: (device codes).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

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.Additional narrative: udi: (b)(4).

Event Description

Ppf alleges dislocation with closed reduction, metal wear and metallosis.

Event Description

Complaint description: the litigation alleges the patient suffers from pain and discomfort.Update 9/23/2016: pfs and medical records received.After review of the medical records for mdr reportability, a correct doi was provided.Lab levels indicated the cobalt and chromium levels are above 7ppb.Part/lot is being updated.The complaint was updated on:10/18/2016.Update 03/15/2017: pfs and medical records received.After review of the medical records for mdr reportability, in addition to what was previously reported, the medical records reported that the patient was revised to address breakage (fracture) of prosthetic joint, but the revision surgery notes reported that the patient was revised to address pain, discomfort, and some squeaking, significant effusion, the cup and stem were well fixed and there was no mention of a breakage (fracture) during the actual revision notes.The complaint was updated on: 04/05/2017.Investigation method: examination of the reported devices was not possible as they were not returned.A search of the complaints databases and/or a review of device history records were not possible as the required product/lot code combinations were not provided.The investigation can draw no conclusion regarding the reported event with the information available.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 device(s) 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 complaint database search did find additional related reports against the metal liner product code and lot number combination.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 femoral stem and acetabular cup 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.The lot code for the femoral stem associated with this report is not known.Investigation summary: the litigation alleges the patient suffers from pain and discomfort.Examination of the reported devices was not possible as they were not returned.A search of the complaints databases and/or a review of device history records were not possible as the required product/lot code combinations were not provided.The investigation can draw no conclusion regarding the reported event with the information available.Based on the inability to determine root cause, the need for corrective action has not been indicated.Update 9/23/2016: pfs and medical records received.After review of the medical records for mdr reportability, a correct doi was provided.Lab levels indicated the cobalt and chromium levels are above 7ppb.Part/lot is being updated.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.  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.  .

Event Description

Pfs alleges weight loss, anxiety, depression and metal anguish.

• Brand Name: PINN SECTOR W/GRIPTION 50MM
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 5888650
• MDR Text Key: 52512695
• Report Number: 1818910-2016-25478
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K071784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/04/2020

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: Health Professional
• Device Catalogue Number: 121732050
• Device Lot Number: E76L21000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/26/2016
• Initial Date FDA Received: 08/19/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 07/06/2018; 02/21/2019; 11/28/2019; 02/04/2020
• Supplement Dates FDA Received: 09/30/2016; 10/20/2016; 11/28/2016; 04/05/2017; 07/27/2018; 03/01/2019; 12/18/2019; 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Weight: 68