MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX54OD; METAL ACETABULAR LINER

Model Number 1218-87-354

Device Problems Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Fatigue (1849); Foreign Body Reaction (1868); Hearing Impairment (1881); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Anxiety (2328); Distress (2329); Numbness (2415); Joint Laxity (4526); Metal Related Pathology (4530); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/02/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pinnacle litigation complaint received ad 29 mar 2022.Patient was revised was due to heavy metal poisoning from toxic heavy metals.Also alleges pain, injury, metal stained tissue, metal wear, loss of enjoyment of life, limitation of daily activities, emotional trauma and distress.Doi: (b)(6) 2011, dor: (b)(6) 2021, unknown hip.

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 manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.

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 blood heavy metal increased & 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

After review of the medical records, the patient was revised to address right hip pain, elevated metal ions, and pseudotumor due to metal-on-metal reaction tha.Doi: 2011; dor: (b)(6) 2021; right hip.

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.Corrected: d10, h6 (clinical code, medical device problem code).

Event Description

Medical records were received: in addition to what was previously reported and after review of the medical records the patient was revised to address neuropathy due to metal ion toxicity and polyneuropathy.Clinic visit reported right hip pain, numbness, limited adl, noise generation, adverse local tissue reaction with alval, positive for arthralgias, bursitis trochanteric, stiffness in the joints and muscle.Patient had some gait instability sometimes requires a cane, fatigue, visual problem, difficult hearing, weakness, depressed and anxious.Doi: (b)(6) 2011; dor: (b)(6) 2021; right hip.

Event Description

On (b)(6) 2021, patient was revised due to a painful metal on metal right total hip arthroplasty with elevated metal ions and pseudotumor.

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).Investigation summary : the device associated with this report was not returned to depuy synthes for evaluation.Review of the photographic and x-ray evidence cannot confirmed the reported allegation.Based on the quality of the photo and the insufficient evidence it is not possible to observed signs of wear or deterioration of metal material on the inner surface of the acetabular liner.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.

Manufacturer Narrative

Product complaint (b)(4) investigation summary pinnacle litigation complaint received ad 29 mar 2022.Patient was revised was due to heavy metal poisoning from toxic heavy metals.Also alleges pain, injury, metal stained tissue, metal wear, loss of enjoyment of life, limitation of daily activities, emotional trauma and distress.The product was not returned to depuy synthes, however photos were provided for review.See attachment (b)(4) _x-ray_images-received on (b)(6) 2023).The photo/x-ray investigation was not able to confirm the complaint since no signs of wear or anything indicative of audible sound were observed on the provided evidence.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was unconfirmed as the observed condition of the pinnacle mtl ins neut36idx54od would not contribute to the complained device issue.Based on the investigation findings and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.H10 additional narrative: added: b6.

• Brand Name: PINNACLE MTL INS NEUT36IDX54OD
• Type of Device: METAL ACETABULAR LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14111234
• MDR Text Key: 289258895
• Report Number: 1818910-2022-06758
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003523
• 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: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Model Number: 1218-87-354
• Device Catalogue Number: 121887354
• Device Lot Number: 3213781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2011
• 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: APEX HOLE ELIM POSITIVE STOP; APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +1.5; ARTICULEZE M HEAD 36MM +1.5; PINN CAN BONE SCREW 6.5MMX35MM; PINN CAN BONE SCREW 6.5MMX35MM; PINNACLE MTL INS NEUT36IDX54OD; PINNACLE SECTOR II CUP 54MM; PINNACLE SECTOR II CUP 54MM; TRI-LOCK BPS SZ 4 STD OFFSET; TRI-LOCK BPS SZ 4 STD OFFSET; UNK HIP ACETABULAR CUP PINNACLE; UNK HIP ACETABULAR LINER METAL PINNACLE; UNK HIP FEMORAL HEAD METAL; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White