MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT DUOFIX TAP SZ4 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number 157012100

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Bone Fracture(s) (1870); Unspecified Infection (1930); Itching Sensation (1943); Necrosis (1971); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Rash (2033); Sepsis (2067); Tissue Damage (2104); Anxiety (2328); Discomfort (2330); Injury (2348); Depression (2361); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); Not Applicable (3189); No Code Available (3191)

Event Date 04/27/2018

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.Reporter is an attorney.

Event Description

Pinnacle litigation records received.Litigation alleges toxic cobalt-chromium metal debris to be released into patient's soft tissue surrounding the implant.The patient began to have difficulty with normal everyday tasks, experienced extreme pain, difference in leg length made walking difficulty and there was also a grinding sensation present while walking.Sitting and standing caused her extreme discomfort.The surgeon informed her that she had elevated metal ions.During revision surgery it was discovered that the implant had caused significant metallosis in the soft tissues and blackened discolored tissue throughout the hip.Doi: (b)(6) 2007; dor: (b)(6) 2018; (right hip).

Manufacturer Narrative

Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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.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. .

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.Product complaint # (b)(4).Investigation summary
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> 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, a follow-up medwatch will be filed as appropriate.

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. .

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. udi: (b)(4).

Event Description

Pff alleges metal wear, metallosis and elevated metal ions.After review of medical records, patient was revised to address pain due to prosthetic infection and metallosis without loosening and with retroacetabular and limited proximal femoral osteolysis.It was also reported of minor posterior edge greater trochanter fracture and medial wall acetabular fractures.Added expiration date, manufactured date, product and lot details of head and liner.Added manufactured date, product and lot details of stem.Added patient age and dob.Updated patient initials.

Manufacturer Narrative

Product complaint #
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> (b)(4).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.  additional narrative: added: (patient codes).

Event Description

Patient communication received.As stated " received a metal on metal hip replacement 2006.Went for 12 years to multiple doctors who refused to take care of me.Severe worsening pain from the day it was placed until 2018.In this time i experienced pain, neuropathy, rashes, itching,anxiety ,depression,cognitive issues.Made fun for years because of the noises the hip made with every step.All doctors ever did were x-rays and they always stated the hip was in place.The fda allowed this device into the market and i have been severely injured and have lifelong disabilities because of the metal on metal hip.Now, completely unable to return to my career as a registered nurse,metal levels over 49,sepsis, pseudotumors, necrosis and bone loss.Antibiotic spacer placed 2018 for over 8 months and revision on 2018.All completed at medical center".

• Brand Name: SUMMIT DUOFIX TAP SZ4 HI OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7824100
• MDR Text Key: 118473490
• Report Number: 1818910-2018-67833
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K011489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/03/2018

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: 157012100
• Device Lot Number: BL4GF1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/03/2018
• Initial Date FDA Received: 08/28/2018
• Supplement Dates Manufacturer Received: 09/28/2018; 03/04/2019; 03/04/2019; 03/08/2019; 12/02/2019
• Supplement Dates FDA Received: 09/28/2018; 03/13/2019; 03/21/2019; 03/29/2019; 12/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR