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 Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Distress (2329); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)

Event Date 06/27/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).The device catalog number is unknown; therefore, udi # is unavailable.Initial reporter occupation: lawyer.(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

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, physical disability, emotional trauma, and distress.Doi: (b)(6) 2009 - (b)(6) 2022.(unk 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), was not possible because the required lot code was not provided.H6 clinical code: metal related pathology (e1618) is used to capture metal poisoning and blood heavy metal increased.

Event Description

After review of the medical records the patient was revised to address metallosis and pseudotumor resulting to limited adl.Operative finding reported a very large 10 pseudotumor was found in the muscle plane underneath the tfl and extending over the vastus distally measuring 15 cm in length by 12 cm in width with fluid distention present.Metallosis was found in the fluid.During capsulectomy extraction instruments were used in a sequential manner and the rim of the shell cup was attempted to be released.It was apparently cold welded.It would not move.After attempts in breaking 1 instrument, it was decided to extract the cup.Doi: (b)(6) 2009, dor: (b)(6) 2022, affected side: right 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 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.

• 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, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15916059
• MDR Text Key: 304810413
• Report Number: 1818910-2022-24308
• 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
• Report Date: 12/05/2022

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: 11/14/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 03/16/2023; 08/21/2023
• Supplement Dates FDA Received: 03/21/2023; 09/05/2023
• 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: SIZE 13 CORAIL HIGH OFFSET STEM; SIZE 54 MM PINNACLE CUP; UNK HIP ACETABULAR LINER METAL; UNK HIP ACETABULAR LINER METAL; UNK HIP FEMORAL HEAD METAL; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 93 KG