MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-01-056

Device Problem Corroded (1131)

Patient Problems Ossification (1428); Adhesion(s) (1695); Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Necrosis (1971); Pain (1994); Pocket Erosion (2013); Scar Tissue (2060); Synovitis (2094); Distress (2329); Discomfort (2330); Muscle/Tendon Damage (4532); Unspecified Tissue Injury (4559); Physical Asymmetry (4573); Swelling/ Edema (4577)

Event Date 12/23/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.Component code: appropriate term/code not available ((b)(4)) used to capture no findings available.Investigation summary
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> 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 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

Pinnacle mom litigation records received.Litigation alleges heavy metal poisoning from the toxic heavy metals resulting in injury, swelling hip, pain, necrotic tissue, pseudotumor, damage muscle and bone.Operative note reported a large 1-2 l of fluid, extensive destruction of the periarticular soft tissues, hip abductor destruction, multiple fluids collection and copious amount of chocolate brown fluid, metal wear.Patient is also experiencing emotional trauma and distress.Plaintiff is seeking compensatory damages.Doi: (b)(6)2010; dor: (b)(6) 2020; hip unknown.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.All available x-rays were reviewed found nothing indicative of a device nonconformance or a relation with the reported adverse event.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.Clinical symptoms code: swelling/ edema (e2338) used to capture swelling and edema and unspecified tissue injury (e2015) used for bone injury and soft tissue injury.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 indicate that the patient was revised to address abductor repair of the right hip.The operative note reported to have extensive destruction of the periarticular soft tissues.The abductor insertion was avulsed and eroded in the anterior third of the greater trochanter.There were copious amounts of chocolate brown fluid evacuated, scar tissue, capsular sleeve, and repair had been eroded by pseudotumor.A sciatic neuroplasty was performed.Thorough debridement is done of the pseudotumor, nodular synovitis.The femoral head showed severe corrosive debris.Mild bone loss in the porous coating no need for stem revision.There is a significant debridement of the scar and heterotopic ossification was done in the femur.The clinical visit reported fluid build on his lateral hip and for examined.The patient had pain and weakness and some other vague constitutional symptoms which may or may not be related to his hip.Positive for arthralgias and joint swelling, tenderness in the greater trochanter and lateral.Leg length is 5-8 mm short.Associated mild soft tissue edema.Mri impression with large appearing periprosthetic fluid collection with large pseudotumor.Elevated metal ions both in urine and plasma.Mechanical complication of internal right hip, pain due to prosthetic devices, joint disorder, synovitis and tendonitis, injury of adductor muscle, fascia, and tendon of the right thigh.Replacement of right hip joint, femoral with a ceramic open approach, excision of the right hip joint, repair of right hip muscle, and reposition of the sciatic nerve.In addition, the litigation alleges severe pain, discomfort, erosion, pseudotumor, elevated metal ions, swelling, difficulties walking, standing, climbing, and limited adl inability to sleep.

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.

• Brand Name: PINNACLE 100 ACET CUP 56MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16530407
• MDR Text Key: 311287682
• Report Number: 1818910-2023-05689
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295008576
• UDI-Public: 10603295008576
• 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: 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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2019
• Device Model Number: 1217-01-056
• Device Catalogue Number: 121701056
• Device Lot Number: D5GE31000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/13/2023
• Supplement Dates Manufacturer Received: 05/20/2023; 06/20/2023; 09/18/2023
• Supplement Dates FDA Received: 05/30/2023; 06/20/2023; 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2009
• 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: AML HIGH OFFSET LG STAT 15.0MM; APEX HOLE ELIM POSITIVE STOP; ASPHERE M SPEC 12/14 40 +5; PINNACLE 100 ACET CUP 56MM; PINNACLE MTL INS NEUT40IDX56OD
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 93 KG