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

Catalog Number UNK HIP FEMORAL STEM SUMMIT

Device Problems Degraded (1153); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Deformity/ Disfigurement (2360); Test Result (2695); No Code Available (3191); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 12/19/2016

Event Type  Injury  

Manufacturer Narrative

(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

Litigation record received.Litigation alleges elevated cobalt levels in the blood resulting to pain, scarring, disfigurement and loss of function.Doi: 2009; dor: (b)(6) 2016; unknown 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 device history record (dhr) review, was not possible because the required lot number was not provided.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Medical records reported that the patient asr resurfacing was revised due to acetabulum fracture transverse posterior wall, developed collapse posterior wall with subluxation of femoral head into posterior wall hardware with grooving of the head and loss of articular cartilage.Asr resurfacing was revised with pinnacle construct on (b)(6) 2009 and pinnacle implants were revised on (b)(6) 2016 however, reason for revision were unknown.

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 device history record (dhr) review, was not possible because the required lot number was not provided.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.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.H10 additional narrative: replaced surgical intervention with device revision or replacement.

Event Description

After a review of medical records patient was revised due to failed mom tha with metallosis and abductor necrosis, operative notes indicated elevated metal ions however laboratory results showed below normal level, mri shows consistent mom corrosion and pseudotumor formation.Upon entering the joint, the fluid was under tension and had evidence of metal debris.The taper and bearing surface of the femoral head had corrosion.There was evidence of corrosion at the taper of the liner acetabular component interface with pseudomembrane formation on the undersurface of liner.The femoral stem was in excessive anteversion minimizing combined version malpositioning.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.

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 device history record (dhr) review, was not possible because the required lot number was not provided.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.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK HIP FEMORAL STEM SUMMIT
• Type of Device: HIP FEMORAL STEM
• 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 ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9343647
• MDR Text Key: 184570453
• Report Number: 1818910-2019-117055
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/23/2019

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 SUMMIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/23/2019
• Initial Date FDA Received: 11/19/2019
• Supplement Dates Manufacturer Received: 12/11/2019; 12/13/2021; 07/11/2023; 07/28/2023
• Supplement Dates FDA Received: 12/16/2019; 12/22/2021; 07/27/2023; 07/30/2023
• 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
• Treatment: UNK HIP ACETABULAR LINER METAL PINNACLE; UNK HIP FEMORAL HEAD METAL
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male