MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP IMPLANT

Catalog Number UNK HIP

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Cyst(s) (1800); Edema (1820); Foreign Body Reaction (1868); Pain (1994); Discomfort (2330); Osteolysis (2377); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 07/19/2012

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(b)(4) used to capture the surgical intervention.Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

New (b)(4) record created in order to update (b)(4) (legal system) complaint number (b)(4).Reason for original complaint ¿ patient was revised to address minimal metallosis and an osteolytic cyst, which were causing pain.Update rec'd 4/30/2015 - litigation papers received.In addition to what was previously reported, litigation alleges the patient suffers from discomfort, inflammation, and large amounts of toxic cobalt chromium metal ion particles to be released into the blood, tissue, and bone.An unknown stem is being added to address allegations of elevated toxic metal ions.Update ad 21 aug 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets record.In addition to what were previously alleged, ppf alleges loosening of cup.Doi: (b)(6) 2005 - dor: (b)(6) 2012 (right hip).Bilateral:(b)(4) (left).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> 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.

• Brand Name: UNKNOWN HIP IMPLANT
• Type of Device: HIP IMPLANT
• 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 ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9134875
• MDR Text Key: 166418787
• Report Number: 1818910-2019-106784
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/19/2012

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 09/30/2019
• Supplement Dates Manufacturer Received: 12/10/2019
• Supplement Dates FDA Received: 01/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 68