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

Catalog Number 157011120

Device Problem Naturally Worn (2988)

Patient Problems Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Nausea (1970); Loss of Range of Motion (2032); Vomiting (2144); Discomfort (2330); Depression (2361); Numbness (2415); Ambulation Difficulties (2544); Joint Laxity (4526); Metal Related Pathology (4530); Physical Asymmetry (4573); Swelling/ Edema (4577)

Event Date 11/09/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4-the device catalog number is unknown.Therefore, udi is unavailable.E3 initial reporter occupation: lawyer.E3 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.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

Event Description

The patient was revised due to pain.Patient had metal liner and metal head.Doi: jun 3,2009.Dor: (b)(6) 2021.

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.

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.H6: metal related pathology (e1618) is being utilized to capture metal poisoning & 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 Description

Medical records received.In addition to what was previously reported in the medical records.After review of the records the patient was revised to address hip pain, left tha instability and metal on metal wear.Patient had elevated chromium and cobalt metal ions.Operative findings were metallosis with pseudotumor.Frozen section showed no acute inflammation.There is significant amount of fluid came out of the hip.Found a pseudotumor within the capsule.Trunnionosis within the trunnion.Patient had mild leg length discrepancy.Clinical visit reported patient developed intermittent nausea and vomiting that lasted 8-10 years after implantation.Patient had metal poisoning with chromium level above 50.Developed increase left knee pain and feelings of buckling and catching.Pain localized on the anterior medial aspect of her knee resulting to discomfort, weakness, walking difficulty and limited range of motion.Medical records ad 30 oct 2023 were reviewed by a clinician for adverse events.On (b)(6) 2021, the patient underwent a left hip revision for elevated cobalt and chromium levels as captured in this current pc.During the revision, a pinnacle dual mobility liner, bi-mentum pe liner, and articul/eze femoral head were placed.On (b)(6) 2021, the patient visits the emergency department after falling and has knee pain and left lower extremity weakness.She is also concerned about pus at the top of her incision site.The physician determined there was minimal wound dehiscence and xrays were clear, so no intervention was required.On (b)(6) 2021, the patient visits the emergency department for left hip pain after falling 3 times due to her left knee buckling.No intervention was performed on (b)(6) 2022, the patient has a clinic visit with complaints of redness and drainage from her left hip incision.No indication of treatment if there was any.On (b)(6) 2022, continues to complain of left knee pain and instability as well as rib pain ¿ all unrelated to the left hip revision.On (b)(6) 2022, the patient has a clinic visit for four falls since her left revision.She has increasing left knee pain and feelings of buckling and catching ¿ noted to be secondary to left knee arthritis.A related pc will be created to capture the post-revision falls and left hip pain.Doi: (b)(6) 2009; dor: (b)(6) 2021; left hip 1st revision.

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.

Event Description

Medical records received.On (b)(6) 2024, the patient has pain, and she feels the left hip is "puffy." the patient is positive for bacillus non anthracis and metal levels of both co/cr remain above 10.There is plan for a revision secondary to infection with placement of an antibiotic spacer.Also the entire construct is planned to be removed in order to also remove "the metal generator in her hip possibly from damaged trunnion." there are no revision notes provided at this time.There is xray notation of a healed distal femoral fracture though patient has a history of a motor vehicle accident that caused this prior to the original l tha.

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.

Event Description

After a review of the medical records received.Clinical visit on (b)(6) 2010 reported troubles with bending left knee and leg pain.On (b)(6) 2011 reported depression, restlessness, disability, malaise, and fatigue.On (b)(6) 2012 reported left legs swollen and leg edema.On (b)(6) 2012 reported leg and back hurts, and pain in the hip.On (b)(6) 2013 reported numbness in left leg.On (b)(6) 2014 reported nausea and body aches.

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: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records received.On (b)(4) 2011, the patient had a left knee arthroscopy to address left knee arthrofibrosis.On (b)(4) 2016, the patient has a history of acute right knee pain.The patient had a past surgical history of left hip replacement and left intramedullary femur nailing.On (b)(4) 2019, the patient reports having right buttock and lateral hip pain.The patient is reported to have piriformis syndrome on the right side.On (b)(4) 2020, the patient had bilateral hip pain.Right, buttock pain is the worst.The patient reports that their gait is uneven due to the left hip and left leg being shorter.On (b)(4) 2020 bunion and hammer toes right foot, and hammer toe, left 4th toe fusion.

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 and b6.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SUMMIT POR TAPER SZ6 HI OFF
• Type of Device: JRN : 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: 17611788
• MDR Text Key: 321836119
• Report Number: 1818910-2023-17455
• 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,Followup
• Report Date: 08/24/2023

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 Expiration Date: 04/22/2019
• Device Catalogue Number: 157011120
• Device Lot Number: DP7BB1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/10/2023
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 09/04/2023; 11/16/2023; 02/29/2024; 03/11/2024; 03/20/2024; 04/23/2024
• Supplement Dates FDA Received: 09/08/2023; 11/27/2023; 03/11/2024; 03/14/2024; 03/25/2024; 05/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2009
• 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: ARTICULEZE M HEAD 36MM +15.5; PINN CAN BONE SCREW 6.5MMX35MM; PINN CAN BONE SCREW 6.5MMX35MM; PINNACLE MTL INS NEUT36IDX54OD; PINNACLE SECTOR II CUP 54MM
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White