MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Corroded (1131); Degraded (1153)

Patient Problems Foreign Body Reaction (1868); No Code Available (3191)

Event Date 09/10/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).

Event Description

The primary surgery was performed on (b)(6) 2008 via tha.After the surgery, the cup¿s setting angle became steep over time.There was fear of armd occurring due to mom liner, so the surgeon performed the revision surgery on (b)(6) 2020.During the revision surgery, the pseudotumor was not found, but the black-ring was found at the head neck junction, the surgeon judged trunnionosis.After removing the liner and the screw, the surgeon checked the fixation of the cup, the cup was loosened and removed easily.The surgeon implanted a pinnacle gription cup with screws and a poly liner.Due to trunninosis, the surgeon considered to remove the stem, however, there was fear of remaining breakage fragment of the stem because the surgeon found a possibility of the breakage of distal stem¿s slot by x-ray photos.The surgeon relinquished to remove the stem.The surgeon replaced the head, the stem was remained.The surgery was completed without any surgical delay.No further information is available.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Examination of the provided x-ray image is unable to confirm an allegation of reaction to metal debris or corrosion of the device.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.H6 component code: appropriate term/code not available (g07002) is used to capture product not returned.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10562592
• MDR Text Key: 208153642
• Report Number: 1818910-2020-20575
• 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: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCREW; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention