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

Catalog Number UNK HIP HEAD METAL

Device Problem Naturally Worn (2988)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Inflammation (1932); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Synovitis (2094); Distress (2329); Fibrosis (3167); Metal Related Pathology (4530); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/30/2020

Event Type  Injury  

Event Description

Pinnacle mom litigation record received.Litigation alleges heavy metal poisoning from toxic metals release by the pinnacle system resulting to metallosis, scar tissue formation, hip pain, metal wear and limited activities of daily living.Plaintiff also suffer from emotional trauma and distress seeking compensation for all the damages.Doi: (b)(6) 2009; dor: (b)(6) 2020; right hip.

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.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.

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.

Event Description

Medical records received.After review, the synovium was noted to be pale with patchy areas of gray and black streaking suggestive of possible metal staining but without gross evidence of inflammation, granulation, friability, or necrosis, posteriorly, there were some areas of patchy, nodular dark yellowish fibrlnous appearing capsular synovial tissue.However, the clinical picture was that of metallosis/altr rather than periprosthetic joint infection.

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.H10 additional narrative: added: a4, b5, h6 blood heavy metal increased h6: metal related pathology (e1618) is being utilized to capture metal poisoning & blood heavy metal increased.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records report failed right total hip arthroplasty secondary to metallosis and adverse local tissue reaction; corrosion and synovitis.Physical exam and imaging studies have raised suspicion for metallosis with adverse local tissue reaction.Cobalt and chromium levels were elevated at 16 and 4.7.Upon entry into the joint there was expression of a moderate amount of slightly blood tinged pale gray-yellow joint fluid.The synovium was noted to be pale with patchy areas of gray and black streaking suggestive of possible metal staining but without gross evidence of inflammation, granulation, friability, or necrosis, posteriorly, there were some areas of patchy, nodular dark yellowish fibrinous appearing capsular syriovial tissue.There was noted to be black metal staining debris on the trunnion and inner surface of the head.

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.

• Brand Name: UNK HIP FEMORAL HEAD METAL
• Type of Device: METAL FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12983318
• MDR Text Key: 282102618
• Report Number: 1818910-2021-27760
• 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
• Report Date: 12/13/2021

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 HEAD METAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/13/2021
• Supplement Dates Manufacturer Received: 03/01/2023; 08/17/2023; 08/29/2023
• Supplement Dates FDA Received: 03/17/2023; 08/28/2023; 08/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK HIP ACETABULAR CUP PINNACLE; UNK HIP ACETABULAR LINER METAL PINNACLE; UNK HIP FEMORAL HEAD METAL; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 103 KG