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.

• 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
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• 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
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• 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

• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/21/2020 Patient Sequence Number: 1