MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SUMMIT DUOFIX TAP SZ7 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-12-135
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Osteolysis (2377); Hematuria (2558); Metal Related Pathology (4530)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Summon email ad (b)(6) 2023 received.Patient alleges suffering heavy metal poisoning from the toxic heavy metals released by the pinnacle system resulting in injury to his muscles and tissue, suffered additional scar tissue formation, and now has a hip replacement with decreased longevity.Additionally, patient suffers 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.Moreover, patient experienced emotional trauma and distress, mental anguish, economic loss.Doi: (b)(6) 2010 dor: (b)(6) 2022 affected side: unknown.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.
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 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, b6 and h6 clinical symptoms code: metal related pathology (e1618) used to capture metal poisoning and blood heavy metal increased.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
After a review of medical records, it was noted that there was significant osteolysis of the proximal femur.Hip capsulectomy was done and during this process, a large significant amount of white hematuria was expressed from the joint.There was extremely high pressure.Significant trunnionosis of the femoral trunnion with the femoral head, significant metallosis with trunnionosis.Affected side: left hip.

• Brand Name: SUMMIT DUOFIX TAP SZ7 HI OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16528957
• Report Number: 1818910-2023-05656
• Device Sequence Number: 5411319
• Product Code: LPH
• UDI-Device Identifier: 10603295060185
• UDI-Public: 10603295060185
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K193398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 1570-12-135
• Device Catalogue Number: 157012135
• Device Lot Number: D59E11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 09/06/2023
• 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: ASPHERE M SPEC 12/14 40 -2; PINN SECTOR HA ACET CUP 58MM; PINNACLE MTL INS NEUT40IDX58OD; SUMMIT DUOFIX TAP SZ7 HI OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 113 KG