MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PRODIGY LG STAT SHT LT 12.0MM; PRODIGY HIP STEM : HIP FEMORAL STEM

Catalog Number 152046050

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

Patient Problems Pain (1994); Test Result (2695); No Code Available (3191)

Event Date 06/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.(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 records received.Litigation alleges excessive levels of chromium and cobalt, pain, suffering and emotional distress.Plaintiff claims damages as a result of the injury to herself, economic loss and loss of services.Doi: (b)(6) 2009, dor: (b)(6) 2016, left hip.

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.

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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Udi (b)(4).

• Brand Name: PRODIGY LG STAT SHT LT 12.0MM
• Type of Device: PRODIGY HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10370191
• MDR Text Key: 201834004
• Report Number: 1818910-2020-17648
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K150862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 152046050
• Device Lot Number: C2BBJ1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVES 12/14 +2; ASR ACETABULAR CUPS 54; ASR UNI FEMORAL IMPL SIZE 47; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL AUGMENT; UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR