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

Catalog Number UNK HIP FEMORAL HEAD METAL

Device Problems Degraded (1153); Naturally Worn (2988)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 04/28/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint#: (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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.

Event Description

Metal on metal hip medical records received.After review of the medical records the patient was revised to address failed left tha due to metal on metal sensitivity reaction.Operative note reported pseudotumor with a large amount of fluid which had penetrated the abductor muscles and to the level of greater trochanteric bursa.This was very dark fluid with dark staining of the appositional membrane of the pseudotumor.There was minimal dark staining of the trunnion or interior of the head.The dissection was quite difficult due to marked scarring.Left hip metallosis and necrotic tissue.This is a left hip revision head and liner exchange.Doi: unknown; dor: on (b)(6) 2022; 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).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: h6 health effect - clinical code & medical device problem code.H6: metal related pathology (e1618) is being utilized to capture blood heavy metal increased & metal poisoning.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Plaintiff was implanted with a mom pinnacle system in plaintiff's hip on (b)(6) 2006 under the care of surgeon.Plaintiff suffered heavy metal poisoning from the toxic heavy metals released by the pinnacle system resulting in injury and requiring surgery to remove the defective hip replacements.Plaintiff was forced to undergo surgical removal of the defective pinnacle system from plaintiffs hip due to heavy metal poisoning on (b)(6) 2023 under the care of surgeon, plaintiff was required to undergo surgical removal of the defective system, suffered injury to his muscle and tissue, suffered additional scar tissue formation, and now has a hip replacement with decreased longevity.Plaintiff suffered injuries, including but not limited to significant pain, injury caused by metallosis, metal wear, metal poisoning, loss of enjoyment of life, and limitation of daily activities.Doi: on (b)(6) 2006, dor: on (b)(6) 2023, left hip.

• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17396645
• MDR Text Key: 319834180
• Report Number: 1818910-2023-15222
• 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: 07/26/2023

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: 07/17/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 08/17/2023; 09/18/2023; 10/05/2023
• Supplement Dates FDA Received: 08/20/2023; 10/03/2023; 10/05/2023
• 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: UNK HIP ACETABULAR LINER METAL.; UNKNOWN HIP ACETABULAR CUP.; UNKNOWN HIP FEMORAL STEM.
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male