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

Catalog Number 136554000

Device Problems Corroded (1131); Material Disintegration (1177); Metal Shedding Debris (1804); Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923); Naturally Worn (2988); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Ossification (1428); Adhesion(s) (1695); Cardiomyopathy (1764); Congestive Heart Failure (1783); Death (1802); Foreign Body Reaction (1868); Pain (1994); Scarring (2061); Tissue Damage (2104); Burning Sensation (2146); Cardiogenic Shock (2262); Discomfort (2330); Joint Dislocation (2374); Osteolysis (2377); Numbness (2415); Test Result (2695); Fibrosis (3167); No Code Available (3191)

Event Date 02/03/2016

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Patient was revised to address metallosis and cup loosening.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.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

Depuy still considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

Update rec'd 10/27/2016- litigation papers received.In addition to what was previously reported, litigation also alleges the patient suffered from pain, discomfort, osteolysis, and severe tissue reaction.Litigation states patient died on (b)(6) 2016 from "refractory cardiogenic shock".

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Update may 26, 2017: legal medical records received.In addition to what was previously alleged, pfs alleges burning sensation, at least one syncopal episode per day, numbness.It also alleges that the patient passed away as a result of congestive heart failure, cardiomyopathy, and cardiogenic shock which was brought due to high level of cobalt toxicity and heavy metal exposure as a result of the failure of the pinnacle implant product that were implanted.After review of the medical records for mdr reportability, it was stated that the patient was revised to address periprosthetic osteolysis metal-on-metal hip replacement, mechanical loosening, severe soft tissue reaction, severe bone loss proximal femur, obesity, and multiple comorbidities including congestive heart failure.Revision operative report stated that there was a scar measuring at least 20 cm full thickness, dark bloody type fluid, lining of the capsule had a thick leathery type of appearance likely due to chronic metal debris, significant destruction well below the lesser trochanter, no severe cystic changes to the proximal femur and appeared only to have thickness and fibrosis, some corrosion on the trunnion, cystic changes around the acetabulum that had to be curetted, severe fragmentation of the proximal femur, and a significant amount of bony remnants consistent with heterotopic ossification.On (b)(6) 2016, x-rays revealed a lucency surrounding the femoral component of the prosthesis on the right side related to removal of prior implants.Clinical notes state that the patient had right hip dislocate early 2015 but managed through the pain.He feels a burning sensation within his joint and pain on right trochanteric bursae.It also stated patient had experienced cardiomyopathy and cardiogenic shock due to systolic chf 20% fraction secondary to cobalt-chromium toxicity from bilateral hip prosthesis.Laboratory values for cobalt and chromium were provided and were above 7 ppb.Stem was added due to the reported high metal level toxicity and corrosion.Part and lot information were provided but not readable.Shall there any new information received, this complaint will be updated.This complaint was updated on: jun 16, 2017.

Manufacturer Narrative

(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

Complaint description: patient was revised to address metallosis and cup loosening.Update rec¿d 10/27/2016- litigation papers received.In addition to what was previously reported, litigation also alleges the patient suffered from pain, discomfort, osteolysis, and severe tissue reaction.Litigation states patient died on (b)(6) 2016 from "refractory cardiogenic shock" there is no new information that would change the existing mdr decision.Complaint was updated 11/08/2016.Update may 26, 2017: legal medical records received.In addition to what was previously alleged, pfs alleges burning sensation, at least one syncopal episode per day, numbness.It also alleges that the patient passed away as a result of congestive heart failure, cardiomyopathy, and cardiogenic shock which was brought due to high level of cobalt toxicity and heavy metal exposure as a result of the failure of the pinnacle implant product that were implanted.After review of the medical records for mdr reportability, it was stated that the patient was revised to address periprosthetic osteolysis metal-on-metal hip replacement, mechanical loosening, severe soft tissue reaction, severe bone loss proximal femur, obesity, and multiple comorbidities including congestive heart failure.Revision operative report stated that there was a scar measuring at least 20 cm full thickness, dark bloody type fluid, lining of the capsule had a thick leathery type of appearance likely due to chronic metal debris, significant destruction well below the lesser trochanter, no severe cystic changes to the proximal femur and appeared only to have thickness and fibrosis, some corrosion on the trunnion, cystic changes around the acetabulum that had to be curetted,severe fragmentation of the proxi mal femur, and a significant amount of bony remnants consistent with heterotopic ossification.On (b)(6) 2016, x-rays revealed a lucency surrounding the femoral component of the prosthesis on the right side related to removal of prior implants.Clinical notes state that the patient had right hip dislocate early 2015 but managed through the pain.He feels a burning sensation within his joint and pain on right trochanteric bursae.It also stated patient had experienced cardiomyopathy and cardiogenic shock due to systolic chf 20% fraction secondary to cobalt-chromium toxicity from bilateral hip prosthesis.Laboratory values for cobalt and chromium were provided and were above 7 ppb.Stem was added due to the reported high metal level toxicity and corrosion.Part and lot information were provided but not readable.Shall there any new information received, this complaint will be updated.This complaint was updated on: jun 16, 2017./ investigation method: no device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination for the cup.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible for the unknown lot codes for the liner and head.The reported event is considered one of the possible complications of joint replacement.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event./ investigation summary: patient was revised to address metallosis and cup loosening.Doi unk - dor (b)(6) 2016 (unk hip).No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.

Manufacturer Narrative

(b)(4).

Event Description

Ppf alleges pseudotumor, loosening of cup, metal wear, metallosis, and elevated metal ions.

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.H6- no code available is to capture surgical intervention.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ARTICULEZE M HEAD 36MM +12
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 5439154
• MDR Text Key: 38266640
• Report Number: 1818910-2016-13441
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/03/2016

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 136554000
• Device Lot Number: 1172603
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/03/2016
• Initial Date FDA Received: 02/16/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 06/22/2018; 01/04/2019; 01/09/2020
• Supplement Dates FDA Received: 04/11/2016; 11/08/2016; 06/21/2017; 06/23/2017; 07/04/2018; 01/14/2019; 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 132