MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX64OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Model Number 1218-87-364

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

Patient Problems Ossification (1428); Abscess (1690); Adhesion(s) (1695); Fever (1858); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Distress (2329); Osteolysis (2377); Thrombosis/Thrombus (4440); Joint Laxity (4526); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/24/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (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

Ad 29 jan 2021: unfiled claim and the medical record received.After review of the medical records, the patient was revised to address septic right hip with suspected osteomyelitis of the innominate and the femur and allergic reaction to metal debris with significant muscle and skeletal necrosis.Operative note reported bone loss, groin pain.And infection.It was also mentioned that there was greenish to yellow thin fluid present.The trunnion was significant for black debris that was present even inside the head that most likely represented metallosis.It was also noted that there was advanced trunnionosis.Doi: (b)(6) 2006, dor: (b)(6) 2019, right hip (first revision).Please see (b)(4) for the third revision.

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 device manufacturing (mre) review will not be performed even when product/lot information is known.Per wi-3430 it has been determined that, for the mom platform and related allegations an mre is not required.

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: b1 (product problem), g2.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h5, 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.H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the 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 Description

Litigation alleges that patient experienced elevated metal ion leaving a ¿very large dead space to manage.Plaintiff has sustained and will continue to sustain severe and debilitating injuries, economic loss, and other damages including, but not limited to, cost of medical care, rehabilitation, permanent instability and loss of balance, immobility, and pain and suffering.Plaintiff has sustained and will continue to sustain severe physical injuries, severe emotional distress, mental anguish, physical disability, economic losses, and other damages, as set forth in this complaint.

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 device manufacturing (mre) review will not be performed even when product/lot information is known.Per (b)(4) it has been determined that, for the mom platform and related allegations an mre is not required.

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).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 were received and stated the following: on (b)(6)2019, a progress reported that patient presented with worsening pain and developed fever.Patient was diagnosed infection and inflammatory response of the internal right hip prosthesis.

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 x-ray evidence was not able to confirmed the reported allegation.In order to observe implant wear, a photo of the explanted device is required.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A1.

Event Description

In addition to what was previously reported in the medical records the patient was revised to address osteolysis.Hip pain, increased polys, bone loss, nonviable abductor, adductor muscle, abscess, scar tissues and hip infection.Operative note reported significant bone loss in the innominate and the femur.The patient had a marked amount of muscle necrosis extended inside the pelvis for at least 10 cm, involved the iliacus and the psoas.The patient also had involvement of the abductors and adductors.Bone loss about the innominate was significant from ischium to supratectal region with significant anteromedial defect and posterolateral defect.The patient had a previous hardinge approach and there was a significant damage to the abductors and very minimal attachment present.Patient had dvt and underwent filter to decrease the risk of pulmonary embolus but still will require anticoagulant treatment and will have a significant risk of bleeding into the pelvis.Muscle loss and the dead space would be certainly difficult to manage.There was limited amount of adductor musculature and most of this was scar present.There was greenish to yellow rather thin fluid present and under pressure about 1 to 2 quarts of fluid was aspirated.This shrank the size of the pelvis considerably.Removal of the trunnion had black debris that was present in the femoral head, around the trunnion, tissue and at the neck.Most likely presented metallosis at the cobalt chrome trunnion interface.Clinical visit reported heterotopic ossification.Debridement of intrapelvic.Psoas and iliacus were completely necrotic, muscle was completely nonviable and avascular.Additional debridement performed at the adductor interval at the patient's previous site of surgery.There as abscess sinus formation in this area over the troch.

• Brand Name: PINNACLE MTL INS NEUT36IDX64OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• 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 LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr; warsaw, IN 46581 ; 6107428552
• MDR Report Key: 11338670
• MDR Text Key: 240980563
• Report Number: 1818910-2021-03177
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2010
• Device Model Number: 1218-87-364
• Device Catalogue Number: 121887364
• Device Lot Number: 1952723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2005
• 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; ARTICULEZE M HEAD 36MM +1.5; PINNACLE 300 ACET CUP 64MM; SUMMIT POR TAPER SZ4 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White