MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX62OD; METAL ACETABULAR LINER

Model Number 1218-87-362

Device Problems Degraded (1153); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Fatigue (1849); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Muscular Rigidity (1968); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Discomfort (2330); Osteolysis (2377); Ambulation Difficulties (2544); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 07/20/2021

Event Type  Injury  

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

Event Description

Pinnacle metal on metal claim letter received.Claim letter alleges pain, discomfort, difficulty walking and elevated metal ions.Mri suggested bilateral foreign body reaction with osteolysis and pseudotumor formation.Patient also suffered the following injuries but are not limited to metallosis, permanent tissue, muscle loss, limited adl and work, medical expenses, psychological and emotional injuries.Patient is seeking compensation for all the damages that have cause him.This is also serve as formal notice of claim and written demand.Doi: (b)(6) 2006; dor: unknown; right hip.

Event Description

Litigation alleges heavy metal poisoning, metallosis and extensive abductor muscle necrosis, metallic stained fluid with metal debris, significant evidence of corrosion of the femoral head, necrotic tissue from the rim of acetabulum, corrosion of the acetabular liner, pseudo membrane formation of the liner due to toxic heavy metal ion poisoning.Plaintiff is also suffering from emotional trauma and distress.

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), was not possible because the required lot code was not provided.

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: a2 (age, birth date).B7, d4 (procode,lot,udi), g4 and h4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d1, d2,d10 and g1.

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 synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese 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 review of the medical records, clinical visit reported bilateral tha suggestive of bilateral foreign body reaction with osteolysis and juxta articular collection/ pseudotumor formation.Left hip lucency is seen surrounding the proximal stem, less conspicuous that on the right, nonspecific multiple areas of heterotopic ossification along the femoral head and lateral to the acetabulum.No component fracture.

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: a4, a5, a6 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: a1, b7, h6 (medical device problem code).

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

In addition to what was previously reported, the patient was revised to address right hip weakness and functional limitations r tha due to metalosis.Doi: (b)(6) 2006.Dor: (b)(6) 2021.Right hip.

Manufacturer Narrative

Product complaint #(b)(4).Investigation summary: the device associated with this report was not returned for analysis.Per the provided evidence, no wear signs were able to be observed on the device.Debris was possible to be observed, however, it cannot be definitely determined that device presented corrosion.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: 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.Added: b5, h6 health effect - clinical code.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, the patient was revised to address, mechanical loosening of the internal right hip prosthetic joint and pain.Clinical visit reported pain, edema, weakness, discomfort, distress, impaired rom, stiffness, and tenderness.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for analysis.Per the provided evidence, no wear signs were able to be observed on the device.Debris was possible to be observed, however, it cannot be definitely determined that device presented corrosion.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: 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.

• Brand Name: PINNACLE MTL INS NEUT36IDX62OD
• Type of Device: METAL ACETABULAR LINER
• 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: 12418132
• MDR Text Key: 270837808
• Report Number: 1818910-2021-19262
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2011
• Device Model Number: 1218-87-362
• Device Catalogue Number: 121887362
• Device Lot Number: 2048439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2006
• Is the Device Single Use?: No
• 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 +8.5; ARTICULEZE M HEAD 36MM +8.5; PINNACLE MULTIHOLE II CUP 62MM; PINNACLE MULTIHOLE II CUP 62MM; TRI-LOCK 10.0MM LAT OFFSET; TRI-LOCK 10.0MM LAT OFFSET; UNK HIP ACETABULAR LINER METAL PINNACLE; UNK HIP FEMORAL HEAD METAL; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White