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

Catalog Number UNK HIP FEMORAL HEAD METAL

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Synovitis (2094); Distress (2329); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)

Event Date 05/08/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The initial reporter occupation: lawyer.(b)(4).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.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.

Event Description

Mom pinnacle litigation record received.Patient alleges heavy metal poisoning from the toxic heavy metal released, pain, injury to muscle and tissue, suffered additional scar tissue formation and will have replacements with decreased longevity, metallosis, ,metal wear, metal poisoning, loss of enjoyment of life, limitation of daily activities, emotional trauma, and distress.Doi: (b)(6) 2008 - dor: unk (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.

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: a2 (dob), a3 and b7.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.Medical records report left hip metal-on-metal failure; significant metallosis throughout the joint; severe synovitis.Some deep acetabular cancellous chip bone grafting.With the graying that would be expected for metallosis, patient had elevated chromium and cobalt in the serum and all this correlated.A synovectomy was performed.Cancellous graft chips and bone were packed into the acetabulum.

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

Severe synovitis was identified during the surgery.The patient had elevated chromium and cobalt in the serum and all this correlated.The hip dislocated.The head removed off the stem.Doi: (b)(6) 2008.Dor: (b)(6) 2023.Affected side: left hip.

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 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: b3, b5, d6b, h6 (clinical code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d2b, h6 (impact code).

• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15895087
• MDR Text Key: 304618212
• Report Number: 1818910-2022-24084
• 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: 12/01/2022

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 FEMORAL HEAD METAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 12/01/2022
• Supplement Dates Manufacturer Received: 11/28/2022; 03/01/2023; 07/14/2023; 08/21/2023
• Supplement Dates FDA Received: 12/06/2022; 03/03/2023; 07/26/2023; 09/06/2023
• 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 LINER METAL; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 109 KG