MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Erosion (1750); Pain (1994); Tissue Damage (2104); Distress (2329); Injury (2348); Osteolysis (2377); Not Applicable (3189); No Code Available (3191)

Event Date 01/16/2017

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Asr litigation and medical records received.Litigation alleges injuries.After review of medical records for mdr reportability, patient was revised to address pain.Revision notes reported of stained black and consistent with the diagnosis of metalosis.The metallic head was removed from the depuy summit stem and an obvious metal reaction present at the trunnion.There was lytic destruction of the acetabulum beneath the component.This was not severe as was encountered on the left side, but this right hip show a 1 x 1.5 mm area of cystic erosion in the superoanterior acetabulum.Upon inserting the acetabular component, a nondisplaced fracture was noted to develop in the bone of the posterior column.It was also stated that patient had an asr components implanted on (b)(6) 2007 and (b)(6) 2007.However, there are no primary surgery notes provided to confirm the correct doi for each affected side.Should there be new information, this complaint will be updated.Doi: unknown; dor: (b)(6) 2017; right hip.This was linked to (b)(4) for the left hip.

Manufacturer Narrative

(b)(4).Investigation summary no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.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 #
=
> pc-(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Asr litigation record received.In addition to what were previously alleged, litigation alleges high metal ions, and emotional distress.Doi: (b)(6)2007.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.On 11/27/2018: additional information received.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.

Manufacturer Narrative

Product complaint # (b)(4).No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.11/27/2018 additional information received.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.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.  .

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 7490149
• MDR Text Key: 107457152
• Report Number: 1818910-2018-58883
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR