MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN SECTOR HA ACET CUP 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121712050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Unspecified Infection (1930); Itching Sensation (1943); Necrosis (1971); Neuropathy (1983); Pain (1994); Rash (2033); Tissue Damage (2104); Anxiety (2328); Discomfort (2330); Injury (2348); Depression (2361); Osteolysis (2377); No Code Available (3191)
Date of Event	04/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.(b)(4).
Event or Problem Description
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.Update: in addition to what were previously alleged, ppf 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.Doi: (b)(6) 2007, dor: (b)(6) 2018, (right hip).
Additional 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.Additional 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: 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 or Problem 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".
Additional Manufacturer Narrative
Product complaint # (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.Added: describe event or problem and (patient codes).

• Brand Name: PINN SECTOR HA ACET CUP 50MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8444294
• Report Number: 1818910-2019-88181
• Device Sequence Number: 277827
• Product Code: LPH
• UDI-Device Identifier: 10603295009153
• UDI-Public: 10603295009153
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K031495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/29/2012
• Device Catalogue Number: 121712050
• Device Lot Number: BV9G71000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 03/08/2019; 12/02/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 03/29/2019; 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR