MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-52-000

Device Problems Corroded (1131); Naturally Worn (2988)

Patient Problems Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Weakness (2145); Distress (2329); Ambulation Difficulties (2544); Test Result (2695); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/21/2019

Event Type  Injury  

Manufacturer Narrative

(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

It was reported that on 2002, cd received a left tha.In 2012, patient began experiencing symptoms of fatigue and difficulties with memory and muscle weakness in her legs.In 2017, patient blood cobalt level was 14.0 ppb and her urine cobalt evel was 109.9.In 2018, her blood cobalt level was 9.4 ppb and her urine cobalt level was 35.6 ppb.She continued experiencing cognitive issue and mental fogginess and had progression of neuropathic weakness in both legs.An fdg pet brain scan showed focal and generalized hypometabolism consistent with chronic toxic encephalopathy.In 2019, her left tha was revised for significantly elevated cobalt level, adverse reaction to metal debris, non -union of trochanteric osteotomy with proximal migration.The replica stem was retained and the cobalt chrome metal-on- metal head articulation was revised to a depuy altrex polyethylene neutral liner and a 36mm + 5 neck length delta option sleeved ceramic head.The bore of the head and the trunion of the retained stem showed moderate corrosion wear.The cobalt chrome femoral head showed a wear elipse.Retrieval analysis of the explant showerd minor corrosion wear of the articulating surface of the cobalt chrome acetabular component.The anteriro capsule and the abductor tendons were involved in the adverse reaction to metallic debris and both required repair.Doi: (b)(6) 2002; dor: (b)(6) 2019; left hip.

Manufacturer Narrative

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.H10 additional narrative: added: a1 and a2.Corrected: h6.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:null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

In addition to what were previoisly alleged, litigation alleges pain, stiffness, instability, cognitive difficulties, metallosis and elevated metal ions.It was also noted during revision that there was adverse reaction to metal debris, psuedotumor and non-union of trochanteric osteostomy and proximal migration.Doi: (b)(6) 2002 - dor: (b)(6) 2019.Left hip.(b)(4) 2nd 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.H10 additional narrative: added: b5, d11, h6 (patient).Corrected: b3, d6, h6 (patient).H6 patient code: removed code for surgical intervention and medical device removal, and replaced with no code available (3191) to capture tendon injury, joint instability, and device revision or replacement.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: 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 clinical code: appropriate term/code not available (e2402) is used to capture metal poisoning.Fatigue (e2312) is used to capture fatigue and weakness) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Pfs alleged that the patient was frustrated due to difficulties in making daily activities, cobalt poisoning and unable to walk long distances.After review of the medical records patient was revised to address adverse reaction to metal debris, generalized brain hypometabolism c/w neurocabaltism and non-union of trochanteric osteotomy with proximal migration.Revision notes reported that the acetabular component was anteverted by 10 degrees.Cobalt level is above normal range.Doi: (b)(6) 2002.Dor: (b)(6) 2019.Left hip (first revision).

• Brand Name: ARTICULEZE M HEAD 36MM +5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9596797
• MDR Text Key: 186191907
• Report Number: 1818910-2020-02005
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033936
• UDI-Public: 10603295033936
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/02/2020

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 Model Number: 1365-52-000
• Device Catalogue Number: 136552000
• Device Lot Number: WC3JD1012
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/02/2020
• Initial Date FDA Received: 01/16/2020
• Supplement Dates Manufacturer Received: 02/19/2020; 07/10/2020; 07/30/2020; 12/02/2020
• Supplement Dates FDA Received: 02/21/2020; 07/24/2020; 07/31/2020; 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP; PINNACLE 300 ACET CUP 52MM; PINNACLE MTL INS NEUT36IDX52OD; REPLICA LG STAT SHT LT 10.5MM
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 68