MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL HEAD METAL

Catalog Number UNK HIP FEMORAL HEAD METAL

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

Patient Problems Ossification (1428); Adhesion(s) (1695); Foreign Body Reaction (1868); Pain (1994); Injury (2348); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); Joint Laxity (4526); Muscle/Tendon Damage (4532); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/02/2016

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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

Pinnacle mom litigation records received.Litigation alleges pain, loss of mobility, elevated metal ions and injury.Doi: (b)(6) 2006.Dor: none reported.Left hip.

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.

Event Description

Pcf has no new allegation.After review of medical records, the patient was revised due to status post left total hip arthroplasty metal-on·metal plus alval (aseptic lymphocyte-dominated vasculitis associated lesion) secondary to metal-on-metal left total hip arthroplasty.Operative notes reported there was noted lo be gross destruction to the gluteus medius attachment in the entire anterior two thirds of the gluteus medius tendon almost off the attachment or the greater trochanter.There was also significant bony destruction along the tip of the greater trochanter and down into the vastus lateralis.There was significant amount of brown serous drainage within the hip and metalosis in the soft tissue surrounding the pseudocapsule to the hip.Trying to be very careful not to avulse all the remainder of the gluteus medius.It was very rigid due to the large amount of heterotopic ossification within it.There was a little bit of laxity in the hip mostly due to removing a significant amount of scar tissue.Doi: (b)(6), 2006.Dor: (b)(6) 2016.Left hip.

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.Device history lot: a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.H10 additional narrative: added: a2 (age, dob), b3, b5, d6a, d6b, d10, h6 (clinical and impact codes) h6 clinical code: appropriate term / code not available (e2402) is used to capture injury (e20).

• Brand Name: UNK HIP FEMORAL HEAD METAL
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8792928
• MDR Text Key: 151110893
• Report Number: 1818910-2019-98364
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD METAL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK HIP ACETABULAR LINER METAL PINNACLE; UNK HIP FEMORAL STEM SUMMIT; UNKNOWN HIP ACETABULAR CUP
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR