MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +8.5; HIP FEMORAL HEAD

Catalog Number 136553000

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

Patient Problems Foreign Body Reaction (1868); Test Result (2695); No Code Available (3191)

Event Date 03/26/2020

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.

Event Description

It was reported that no record of previous surgery was available and no lot information can be provided.Patient had pinnacle mom with a summit stem.Metal ion rates were elevated and surgeon planned to remove metal liner and head and replace with altrx liner and delta ts head.Surgery was performed uneventfully but surgeon noted that he believed the ion levels were likely from trunionosis from the stem head junction as that is where he could see wear and the bearing looked pristine in his opinion.Doi: (b)(6) 2020; dor: (b)(6) 2020; right hip.

Manufacturer Narrative

Product complaint # (b)(4).New information has been added to (patient codes).Patient code: no code available ((b)(4)) used to capture the device revision or replacement.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.

Manufacturer Narrative

Product complaint #
=
> pc-(b)(4).Added: b5 corrected: d6 (additional information received that the date of implantation is unknown.).

Event Description

Additional information indicated that patient had a hip replacement at some time prior to (b)(6) 2020 where the sales representative does not know and when and what was placed.However, he do know that they took out a head, and a liner and replaced them on.

• Brand Name: ARTICULEZE M HEAD 36MM +8.5
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9945174
• MDR Text Key: 187186366
• Report Number: 1818910-2020-10600
• 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: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 136553000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL STEM; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 112