MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 5.0MM DIA TPRD HD PER SCRW 40; BONE SCREWS AND PINS : SCREWS

Catalog Number	125740000
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Scar Tissue (2060); Tissue Damage (2104); Discomfort (2330); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	12/08/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).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.Initial reporter occupation: non-healthcare professional: "attorney".(b)(4).
Event or Problem Description
Litigation alleges the patient suffers from pain, discomfort, and toxic cobalt-chromium metal ions and particles to be released into the blood, tissue and bone.Update: sales rep reported revision surgery.Patient was revised to address instability.Update: in addition to what were previously alleged, ppf alleges loosening of cup, metal wear, metallosis and elevated metal ions.Update: in addition to what were previously alleged, pfs alleges that the patient felt like there was scraping sensation in his hip, walking difficulty and falling down on occasion.Surgeon recommended revision surgery due to loose component and metallosis.After review of medical records, the patient was revised to address cup loosening, metallosis and instability.Revision notes reported that hip was found to be dislocated, synovial scarring, and grossly loose cup.It was also found that the stem is 20 degrees retroverted.The sleeve was left in place and stem was rotated over 40 degrees to provide appropriate anteversion then was re-inserted.Pathology report is positive for acute inflammation.Lab data shows metal ion levels were above 7 ppb.Doi: (b)(6) 2007; dor: (b)(6) 2014; (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.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.

• Brand Name: 5.0MM DIA TPRD HD PER SCRW 40
• Common Device Name: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 8486604
• Report Number: 1818910-2019-89881
• Device Sequence Number: 16612136
• Product Code: JDI
• UDI-Device Identifier: 10603295019893
• UDI-Public: 10603295019893
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K861979
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2014

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: 05/31/2009
• Device Catalogue Number: 125740000
• Device Lot Number: A2XCP4000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 12/30/2019
• 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: Required Intervention
• Patient Age: 53 YR
• Patient Weight: 113