MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ6 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-11-120

Device Problem Degraded (1153)

Patient Problems Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Memory Loss/Impairment (1958); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Osteolysis (2377); Fibrosis (3167); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 03/02/2023

Event Type  Injury  

Event Description

Pinnacle mom litigation record received.Litigation alleges metallosis, pseudotumor mom right tha.It was recommended and underwent revision right tha (the acetabulum was a 36 mm inner diameter, +4 io-degree face changing liner for a 56 mm outer diameter depuy pinnacle shell.The femur was a 36 mm +8.5 ceramic head with a sleeve for a summit stem.) it was alleged that scarred external rotators and pseudo capsule were removed from their insertion into the greater trochanter.There was some brownish yellowish fluid in the joint.Large pseudotumor, encountered in the posterior and inferior aspect of hip joint extended back toward sciatic nerve.Head and femoral component had some corrosion.Pseudocapsule and external rotator was repaired.Clinical note reported mild osteolysis of the trochanter, elevated metal ions, memory issues due to elevated metal ions and reduced mobility.Surgical pathology reported fragments of skeletal muscle and fibroadipose tissue with foci of necrosis, hemorrhage, chronic inflammation, hemosiderosis and metallosis.Fragments of bone with focal medullary fibrosis and metallosis.Doi: (b)(6) 2007; dor: (b)(6) 2021; right hip.

Manufacturer Narrative

Product complaint # (b)(4).E3 initial reporter occupation: lawyer.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.

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 the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

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).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: b5, h6 health effect - clinical code.H6: metal related pathology (e1618) is being utilize to capture 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

Litigation records received.After review, patient was revised due to the following reasons : suffered heavy metal poisoning from the toxic heavy metals released by the pinnacle system resulting in injury.Moreover, patient experience increasing pain, discomfort, and significant memory loss.On (b)(6), 2020, a cobalt chromium metal ion test showed increased metal ion levels to diagnose cobalt toxicity.On (b)(6) 2020, plaintiff learned his metal ion levels had increased and an mri revealed fluid distention of the pseudo-capsule and osteolysis of the trochanter of the right hip.His memory issues were worsening.

• Brand Name: SUMMIT POR TAPER SZ6 HI OFF
• Type of Device: SUMMIT HIP STEM : 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: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16739244
• MDR Text Key: 313301337
• Report Number: 1818910-2023-07928
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295060079
• UDI-Public: 10603295060079
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• 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: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1570-11-120
• Device Catalogue Number: 157011120
• Device Lot Number: A5LHF1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2006
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male