MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT CEMENTED STEM SZ2 STD; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-03-080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Pocket Erosion (2013); Loss of Range of Motion (2032); Distress (2329); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Fibrosis (3167); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.Follow-up is being conducted to obtain legal contact information.If/when the contact information is received, a supplemental med watch report will be submitted.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Pinnacle unf and medical record received.After review of the medical records the patient was revised due to symptomatic metallosis, pseudotumor, alval, elevated metal ions, crp and sedimentation rate resulting to pain, bone necrosis of the proximal femur, large lytic lesion of the ischium, limp and leg length difference.Operative note reported pseudotumor fluid collection approx.15 cc of red serosanguinous fluid.There is significant pseudo-capsular expansion and grade tinted stained tissue consistent with metal debris and damage.Cup looks vertical and anteverted related to spinal pelvic imbalance.Compromise of the abductors by the necrosis of the trochanter from the metallosis damage.Pathology report component had thick fibrosis and synovial lining eroded.Moderate grade for alval.Lab result for chromium and cobalt shows above 7 ppb.Doi: 2009: dor: (b)(6) 2019; left hip.
Additional 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 device history record (mre) review, was not possible because the required lot code was not provided.
Additional 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: e1, g2.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional 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.Update (b)(6) 2021.Update (b)(6) 2021, received did not have any additional details to be added in investigation.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 device history record (mre) review, was not possible because the required lot code was not provided.H10 additional narrative: added: b5 and h6 (clinical codes).H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the bone injury and metal poisoning.
Event or Problem Description
Pinnacle litigation records was received.Litigation alleged that the patient suffered toxic heavy metal poisoning, tissue, muscle, and bone destruction.In addition to what were reported previously.Litigation alleges patient suffered heavy metal poisoning from toxic heavy metals resulting in injury, limited mobility, emotional trauma and distress.Doi: (b)(6) 2009; dor: (b)(6) 2019; left hip.
Additional 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 device history record (mre) review, was not possible because the required lot code was not valid.

• Brand Name: SUMMIT CEMENTED STEM SZ2 STD
• Common Device Name: 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 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11349550
• Report Number: 1818910-2021-03439
• Device Sequence Number: 19692876
• Product Code: JDI
• UDI-Device Identifier: 10603295059523
• UDI-Public: 10603295059523
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/03/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1570-03-080
• Device Catalogue Number: 157003080
• Device Lot Number: XGAB11000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 02/26/2021; 02/28/2021; 04/16/2021; 03/13/2023
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 02/28/2021; 03/02/2021; 04/20/2021; 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICULEZE M HEAD 36MM +1.5.; ARTICULEZE M HEAD 36MM +1.5.; DEPUY SUMMIT SIZE 2.; PINNACLE ACETABULAR CUP SIZE 50.; PINNACLE ACETABULAR CUP SIZE 50.; PINNACLE MTL INS NEUT36IDX50OD.; PINNACLE MTL INS NEUT36IDX50OD.; SUMMIT CEMENTED STEM SZ2 STD.; ARTICULEZE M HEAD 36MM +1.5; DEPUY SUMMIT SIZE 2; PINNACLE ACETABULAR CUP SIZE 50; PINNACLE MTL INS NEUT36IDX50OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 88 KG