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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

Asr legal notification received.It was reported that the patient had a series of check for the past years until x-ray and a check of cobalt-chromium shows elevated metal ion level and the implant was worn.The surgeon requested for revision however upon examination an aortic aneurysm was detected and it will not be possible to perform the revision.Doi: (b)(6) 2005 : dor: none reported (unk hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : investigation summary: the complaint investigation concluded that the event was related to the asr platform which was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.This [name of the device] is not part of the asr family however it did form part of the joint construct.There was no allegation of deficiency with this device.Investigation section: the was no allegation of a deficiency with this device, however this device form part of the joint construct.The complaint investigation concluded that the complaint was related to the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Ongoing post market surveillance is conducted per our procedures for this product.Root cause category: no product problem.E3 initial reporter occupation: lawyer.

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 manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10936714
• MDR Text Key: 219308530
• Report Number: 1818910-2020-25971
• 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,foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2020

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: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/02/2020
• Supplement Dates Manufacturer Received: 12/14/2020; 12/16/2020
• Supplement Dates FDA Received: 12/16/2020; 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL HEAD METAL ASR; UNK HIP FEMORAL SLEEVE ASR; UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL HEAD METAL ASR; UNK HIP FEMORAL SLEEVE ASR
• Patient Outcome(s): Required Intervention